NDC 44224-0699 Easy Care First Aid Kit - Outdoor And Travel

NDC Product Code 44224-0699

NDC CODE: 44224-0699

Proprietary Name: Easy Care First Aid Kit - Outdoor And Travel 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.

Non-Proprietary Name: What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 44224 - Tender Corp Dba Adventure Medical Kits
    • 44224-0699 - Easy Care First Aid Kit - Outdoor And Travel

NDC 44224-0699-5

Package Description: 1 KIT in 1 KIT * .8 mL in 1 PACKAGE (52124-0001-1) * .5 mL in 1 PACKAGE (52124-0008-1) * .5 g in 1 TUBE (52124-0003-1) * 2 TABLET in 1 PACKAGE (52124-0010-1) * 2 TABLET in 1 PACKET (52124-0009-1)

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

NDC Product Information

Easy Care First Aid Kit - Outdoor And Travel with NDC 44224-0699 is a product labeled by Tender Corp Dba Adventure Medical Kits. The generic name of Easy Care First Aid Kit - Outdoor And Travel is . The product's dosage form is and is administered via form.

Labeler Name: Tender Corp Dba Adventure Medical Kits

Dosage Form: -

Product Type: What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

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)
  • WATER (UNII: 059QF0KO0R)
  • WATER (UNII: 059QF0KO0R)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • POVIDONE (UNII: FZ989GH94E)
  • POWDERED CELLULOSE (UNII: SMD1X3XO9M)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • HYPROMELLOSES (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)

Product Labeler Information

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

Labeler Name: Tender Corp Dba Adventure Medical Kits
Labeler Code: 44224
Start Marketing Date: 04-13-2011 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: 12-31-2017 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Easy Care First Aid Kit - Outdoor And Travel Product Label Images

Easy Care First Aid Kit - Outdoor And Travel 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

Active Ingredient

Active Ingredient:                         Benzalkonium Chloride 0.40%

Purpose

Antiseptic

Triple Antibiotic

Use

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

Warnings

Warning:   For external use only.

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

For external use only.

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

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

Otc - Keep Out Of Reach Of Children

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.

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

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: 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 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

Otc - Do Not Use

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

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:  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:  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.

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

Inactive Ingredients

Inactive Ingredient:   Purified water

Other

LOT/EXP:                           Made in CHINA20130301

Otc - Active Ingredient

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

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

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

Otc - Purpose

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

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 due to:the common coldheadachetoothachemuscular achesbackacheminor pain of arthritismenstrual cramps temporarily reduces fever

Storage And Handling

Flammable - keep away from fire or flame.

Other information:Store at room temperature.

Store at 59-86 degree F (15-30 degree C)

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

Description

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

Active Ingredients

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

Indications & Usage

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

Inactive Ingredient

Water

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.

Otc - Ask Doctor

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 a high blood pressure, heart disease, liver cirrhosis, or kidney disease; you are taking a diuretic

Otc - Ask Doctor/Pharmacist

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

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

Otc - Pregnancy Or Breast Feeding

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 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.

Dosage & Administration

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.

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.

General Precautions

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

Otc - When Using

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

* Please review the disclaimer below.