NDC 52124-0113 50 Person Ansi

NDC Product Code 52124-0113

NDC CODE: 52124-0113

Proprietary Name: 50 Person Ansi What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Product Characteristics

Color(s):
WHITE (C48325 - WHITE)
Shape: ROUND (C48348)
Size(s):
10 MM
11 MM
Imprint(s):
44;352
AZ;234
44;157;ASPIRIN
Score: 1

NDC Code Structure

  • 52124 - Genuine First Aid Llc

NDC 52124-0113-1

Package Description: 1 KIT in 1 KIT * .9 g in 1 PACKAGE (52124-0006-1) * .5 mL in 1 PACKAGE (52124-0002-1) * 2 TABLET in 1 PACKAGE (52124-0011-1) * 2 TABLET in 1 PACKAGE (52124-0010-1) * 2 TABLET in 1 PACKAGE (52124-0009-1) * .5 mL in 1 PACKAGE (52124-0008-1) * 10 mL in 1 BOTTLE (52124-0005-1) * .5 g in 1 TUBE (52124-0003-1) * .8 mL in 1 PACKAGE (52124-0001-1) * .9 g in 1 PACKAGE (52124-0004-1)

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

50 Person Ansi with NDC 52124-0113 is a product labeled by Genuine First Aid Llc. The product's dosage form is and is administered via form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 1012100, 1038561, 1046313, 1053490, 204602, 212033, 310965, 313782, 581660 and 797544.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)
  • SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • POWDERED CELLULOSE (UNII: SMD1X3XO9M)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • HYPROMELLOSE (UNII: 3NXW29V3WO)
  • LACTOSE (UNII: J2B2A4N98G)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • POLYDEXTROSE (UNII: VH2XOU12IE)
  • POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
  • POVIDONE (UNII: FZ989GH94E)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • TRIACETIN (UNII: XHX3C3X673)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • POVIDONE (UNII: FZ989GH94E)
  • HYPROMELLOSE (UNII: 3NXW29V3WO)
  • POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • WATER (UNII: 059QF0KO0R)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Genuine First Aid Llc
Labeler Code: 52124
Start Marketing Date: 06-02-2010 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2018 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: I - INACTIVATED, the listing data was inactivated by the FDA. What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

50 Person Ansi Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Otc - Active Ingredient

ACTIVE INGREDIENTS:Benzalkonium Chloride 0.13%Lidocaine HCL 0.5%

Active Ingredient:                                            PurposeBenzalkonium Chloride 0.40%..........    First Aid Antiseptic

Active Ingredient: .........Bacitracin Zinc 400 unitsNeomycin Sulfate 5mg ( equivalent to 3.5 mg Neomycin base)Polymyxin B Sulfate 5000 units

Active Ingredient:Purified Water USP...q.s.

Active Ingredient:                                    Purpose:Benzocaine, 6% w/v..................    Topical AnestheticSD alcohol, 60% w/v..................    Antiseptic

Active ingredient (in each tablet)                       PurposeIbuprofen USP (NSAID*) 200mg . . . . . . . . . . . .Pain reliever/fever reducer*nonsteroidal anti-inflammatory drug

Active Ingredient (in each tablet)                PurposeAcetaminophen 325 mg .............                Analgesic/antipyretic

Active Ingredient (in each tablet)                             PurposeAspirin (NSAID*) 325 mg...............................   Pain Reliever / fever reducer*nonsteroidal anti-inflammatory drug

Active Ingredient:                                        PurposeIsopropyl Alcohol, 70% v/v...............        Antiseptic

Active Ingredient:Ethyl Alcohol 62 percent

Genuine Hand SanitizerInstant GelAntiseptic Handwashwith Vitamin E and AloeKills 99.9 percent of germsWithout WaterActive Ingredient:Ethyl Alcohol 62 percentNet Wt 0.9g (1/32 oz)Manufactured in China ForGenuine First Aid.

Otc - Purpose

Purpose: First aid antiseptic, external analgesicUses: First aid to help prevent infection and for the temporary relief of pain and itching associated with: Minor CutsScrapesBurns

Use: For Professional and Hospital use.  Helps prevent infection.  Antiseptic cleansing of face, hands and body without soap and water.

Uses:  To help prevent infection in: minor cuts;  scrapes;  burns

Uses:For flushing or irrigating the eyes toremove loose foreign material, air pollutants, or chlorinated water.

Use: For the temporary relief of pain and itching associated with minor burns, scrapes and insect bites.

Uses temporarily relieves minor aches and pains due to:the common coldheadachetoothachemuscular achesbackacheminor pain of arthritismenstrual cramps temporarily reduces fever

Usestemporary relief of minor aches and pains associated with:common cold;  headache; toothache; muscular aches;  backache; arthritis; menstrual cramps;  and reduction of fever

Uses    Temporarily relieves minor aches and pains associated with:headache ; muscular aches ; minor arthritis pain ; backache ; common cold ; toothache ; menstrual cramps ; Temporarily reduces fever

Use:    For preparation of skin before injection.

Enter section text here

Warnings

Warnings:For external  use only

Warning:    For external use only.

Warnings:For external use only.

Warning:If you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours, discontinue use and consult a doctor. Do not use if solution changes color or becomes cloudy.

Warnings: For external use only.Avoid contact with eyes.  If this happens, rinse thoroughly with water.

Warnings Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: shock,  facial swelling,  asthma (wheezing) rash, skin reddening, blisters, hives If an allergic reaction occurs, stop use and seek medical help right away.Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomachbleeding. The chance is higher if you: are age 60 or older, have had stomach ulcers or bleeding problems, take a blood thinner (anticoagulant) or steroid drug, take other drugs containing NSAIDs (aspirin, ibuprofen, naproxen, or others), have 3 or more alcoholic drinks every day while using this product, take more or for a longer time than directed

Warnings:Liver warning:    This product contains acetaminophen.Severe liver damage may occur if:  adult takes more than 12 tablets in 24 hours, which is the maximum daily amount; child takes more than 5 doses in 24 hours;  taken with other drugs containing acetaminophen;  adult has 3 or more alcoholic drinks every day while using this product

WarningsReye's syndrome:  Children and teenagers who have or are recovering from chicken pox of flu-like symptoms should not use this product.  When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.Allergy alert:    Aspirin may cause a severe allergic reaction which may include:  hives, skin reddening, facial swelling, rash,  asthma (wheezing), blisters, shock, If an allergic reaction occurs, stop use and seek medical help right away.Stomach bleeding warning:    This contains an NSAID, which may cause severe stomach bleeding.  The chance is higher if you:are age 60 or older; have had stomach ulcers or bleeding problems; take a blood thinner (anticoagulant) or steroid drug; take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others); have 3 or more alcoholic drinks every day while using this product; take more or for a longer time than directed

Warnings:    For external use only.

Warnings:For external use onlyFlammable, keep away from fire or flame

Otc - Do Not Use

Do not use: In eyes, in large quantities, over raw blistered areas, or on deep puncture wounds, animal bites or serious burns, for more than one week

Do not use in the eyes or over large areas of the body.

Do not use:  in eyes;  over large areas of the body; If allergic to any of the ingredients;  for more than one week unless directed by a physician.

Do not use: In eyes, on broken skin, deep puncture wounds.  If unusual redness, swelling, irritation or other symptoms occur, consult a physician immediately.

Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer,  right before or after heart surgery.

Do not use:  with any other drug containing acetaminophen (prescription or nonprescription).  If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist;  for more than 10 days for pain unless directed by a doctor; for more than 3 days for fever unless directed by a doctor

Do not use:  if you have ever had an allergic reaction to any other pain reliever/ fever reducer; right before or after heart surgery; if you are taking a prescription drug for gout, diabetes or arthritis

Do not use: with electrocautery, in the eyes.

Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.

Otc - Keep Out Of Reach Of Children

Keep out of reach of Children.If ingested, contact a Poison Control Center right away.

Keep out of reach of children:  If swallowed, get medical help or contact a Poison Control Center right away.

Keep out of reach of children.If ingested, contact a Poison Control Center right away.

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Keep out of reach of children.  In case of accidental overdose, contact a doctor or Poison Control Center immediately.  Prompt medical attention is critical for adults as well as for children even ifyou do not notice any signs or symptoms.  Do not exceed recommended dosage

Keep out of reach of children.  In case of overdose, get medical help orcontact a Poison Control Center right away.

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions: Clean affected area, Apply small amount not more than 3 times daily.May be covered with a sterile bandage.

DirectionsRemove contacts before using.Twist top to remove.Flush the affected area as needed. ControlRate of flow by pressure on the bottle. Do not touchtip of the container to any surface. Do not reuse.If necessary continue flushing with emergency eyewash or shower.Discard bottle after use.

Directions:do not use more than directed; the smallest effective dose should be used; do not take longer than 10 days, unless directed by a doctor.Adults and Children (12 years and older):  Take 1 tablet every 4 to 6 hours while symptoms persist.  If pain or fever does not respond to 1 tablet, 2 tablets may be used.  Do not exceed 6 tablets in 24 hours, unless directed by a doctor.Children under 12 years: Do not give to children under 12 years of age.

DirectionsAdults and Children                                Take 2 tablets every 4 to 6 hours as12 years of age                                         needed.  Do not take more than 12 tabletsor older                                                        in 24 hours.Children 6-11 years                                    Take 1 tablet every 4 to 6 hours asof age                                                              needed.  Do not take more than 5                                                                         tablets in 24 hours.Children under 6                                          Do not use this regular strength product.years of age                                                  This will provide more than the                                                                           recommended dose (overdose) and could                                                                          cause serious health problems.

Adults and children: (12 years and older) Take 1 or 2 tablets withwater every 4 hours as needed.  Do not take more than 12 tablets in 24 hours, or as directed by a doctor.Children under 12 years:    Do not give to children under 12 years of age.

Directions:Empty contents into palm. Rub hands until gel dissipates. Recommended for repeated use.

Storage And Handling

Other Information:Store at room temperature

Other information:Store at room temperature.

Store in a cool place. For irrigation only. Discard unused portion of the solution.Not for injection.

Flammable - keep away from fire or flame.

Other information:  Store at controlled room temperature; avoid excessive heat 40 degree Celsius (104 degree Fahrenheit); tamper evident sealed packets; do not use any opened or torn packets

Store at 59-86 degree Farenheat (15-30 degree Celcius)

Store at 59 - 86  degree Fahrenheit (15 - 30 degree Celsius); avoidexcessive heat and humidity;  tamper evident sealed packets; Do not use any opened or torn packets

Flammable - keep away from fire or flameStore at room temperature 15-30 degree Celsius (59-86 degree Fahrenheit)

Other Information: Store at 15 to 25 degree Celsius  (59 to 77 degree Fahrenheit)

Otc - Stop Use

Stop use if unusual redness, swelling or other symptoms occur. Consult a physician immediately.

Stop use and consult a doctor:if the condition persists or gets worse;  a rash or other allergic reaction develops

Stop use and ask a doctor If:you experience any of the following signs of stomach bleeding; feel faint; vomit blood; have bloody or black stools; have stomach pain that does get better; pain gets worse or lasts more than 10 days; fever gets worse or lasts more than 3 days; redness or swelling is present in the painful area; any new symptoms appear

Stop use and ask a doctor if: symptoms do not improve; pain gets worse or lasts for more than 10 days; fever gets worse or lasts for more than 3 days; new symptoms occur;  redness or swelling is present; a rare sensitivity reaction occurs

Stop use and ask a doctor ifyou experience any of the following signs of stomach bleeding:feel faint;  vomit blood; have bloody or black stools; have stomachpain that does not get better; pain gets worse or lasts more than 10 days;  fever gets worse or lasts more than 3 days; you have difficulty swallowing; if ringing in the ears or loss of hearing occurs; redness or swelling is present in the painful areas; any new symptoms appear

Stop use if irritation and redness develop. If condition persists for more than 72 hours, consult your doctor.

Stop use and consult a doctor if irritation and redness developand persist for more than 72 hours.

Otc - When Using

Directions: Tear open packet, unfold towelette and use to cleanse desired skin area.  Discard towelette appropriately after single use.

Directions: clean affected area;  apply small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily; may be covered with a sterile bandage

When using this product:take with food or milk if stomach upset occurs

When using this product: take with food or milk if stomach upset occurs

Directionsdo not use more than directedthe smallest effective dose should be useddrink a full glass of water with each dosedo not take longer than 10 days, unless directed by a doctor

Wipe Injection site vigorously and discard.

Inactive Ingredient

Inactive Ingredient:    Purified water

Inactive Ingredients:Sodium Chloride USP                                          44mgMonobasic Sodium Phosphate USP                18mgSodium Phosphate Dibasic USP                       111mg  Edetate Disodium USP                                       10mgBenzalkonium Chloride                                      0.5mgNF (as preservative)

Inactive ingredients: cellulose, corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, polydextrose, polyethylene glycol, povidone, silica, sodium starch glycolate, stearic acid, titanium dioxide, triacetin.

Inactive Ingredients:  hypromellose, polyethylene glycol, propylene glycol, corn starch

Inactive Ingredient:    Purified water.

Description

LOT/EXP:                                    Made in CHINA20130301

Code No.: GUJ/DRUG/G/1080Batch No.:Mfg Date:Exp: Date:

Made in CHINALOT/EXP:

Distributed by GENUINE FIRST AID600 Cleveland Str Suite 400, Clearwater, FL 33755

Distributed by GENUINE FIRST AID600 Cleveland Str Suite 400, Clearwater, FL 33755

Distributed by GENUINE FIRST AID600 Clevelad Str Suite 400, Clearwater, FL 33755

LOT/EXP:                Made in CHINA20140301

Otc - Ask Doctor

Ask a doctor before use if  stomach bleeding warning applies to you; you have a history of stomach problems such as heartburn; you have a high blood pressure, heart disease, liver cirrhosis, or kidney disease; you are taking a diuretic

Ask a doctor before use if the user has liver disease

Ask a doctor before use if: stomach bleeding warning applies to you;  you have a history of stomach problems such as heartburn; you have high blood pressure, heart disease, liver cirrhosis, or kidney disease; you are taking a diuretic

Otc - Ask Doctor/Pharmacist

Ask a doctor before use if you are:taking any other drug containing NSAID (prescription or nonprescription); taking aspirin for heart attack or stroke, because Ibuprofen may decrease this benefit of aspirin; taking any other drug

Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin

Ask a doctor or pharmacist before use if you are:under a doctor's care for any serious condition;  taking any other drug

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

If pregnant or breast-feeding, ask a health professional before use.

If pregnant or breast-feeding, ask a health professional before use. It is especially important to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

General Precautions

Tamper evident sealed packets; do not use any open or torn packets

* Please review the disclaimer below.