NDC 44224-3000 Adventure Medical Kits 1-4 Person First Aid

NDC Product Code 44224-3000

NDC CODE: 44224-3000

Proprietary Name: Adventure Medical Kits 1-4 Person First Aid 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
    • 44224-3000 - Adventure Medical Kits 1-4 Person First Aid

NDC 44224-3000-1

Package Description: 1 KIT in 1 KIT * .5 g in 1 TUBE (52124-0003-1) * .5 mL in 1 PACKAGE (52124-0008-1) * 2 TABLET in 1 PACKET (52124-0009-1) * 1 CAPSULE in 1 PACKET (47682-182-46) * 2 TABLET, FILM COATED in 1 PACKET (47682-175-46) * 2 TABLET in 1 PACKAGE (52124-0011-1) * .8 mL in 1 PACKAGE (52124-0001-1)

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

NDC Product Information

Adventure Medical Kits 1-4 Person First Aid with NDC 44224-3000 is a product labeled by Tender Corp Dba Adventure Medical Kits. The generic name of Adventure Medical Kits 1-4 Person First Aid 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)
  • 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)
  • GELATIN (UNII: 2G86QN327L)
  • D&C RED NO. 28 (UNII: 767IP0Y5NH)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • CROSPOVIDONE (UNII: 68401960MK)
  • HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
  • POVIDONE (UNII: FZ989GH94E)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • TRIACETIN (UNII: XHX3C3X673)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • 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: Tender Corp Dba Adventure Medical Kits
Labeler Code: 44224
Start Marketing Date: 08-26-2010 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: 12-31-2017 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.

Adventure Medical Kits 1-4 Person First Aid 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 Ingredient: .........Bacitracin Zinc 400 unitsNeomycin Sulfate 5mg ( equivalent to 3.5 mg Neomycin base)Polymyxin B Sulfate 5000 units

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)                      PurposeAspirin (NSAID*) 325 mg...............................   Pain Reliever / fever reducer*nonsteroidal anti-inflammatory drug

Active Ingredient (in each tablet)                      PurposeAcetaminophen 500 mg...............................   Pain Reliever / fever reducer

Active Ingredient (in each tablet)                      PurposeDiphenhydramine Hydrochloride 25mg...............................   Antihistimine

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

Otc - Purpose

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

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

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

Purpose: Pain reliever, fever reducer

Purpose: Antihistimine

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

Warnings

Warnings:For external use only.

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

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

WarningsLiver Warning: This product contains acetaminophen. Sever liver damage may occur if you take: more than 8 tablets in 24 hours, which is the maximum daily amount; with other drugs containing acetaminophen; 3 or more alcoholic drinks every day while using this product.

Warnings Ask a doctor before useif you have:a breathing problem such as emphysema or chronic bronchitisglaucomadifficulty in urination due to enlargement of the prostate glandif you are:taking any drugs for asthma taking sedatives or tranquilizers

Warning:   For external use only.

Otc - Do Not Use

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:  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 any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminiophen, ask a doctor or phramacist. 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 in the eyes or over large areas of the body.

Otc - Stop Use

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

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

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.  In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms

Do not exceed recommended dosage. Keep this and all drugs out of the reach of children. In case of accidental overdose, contact a physician or posion control center immediately. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.

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

Otc - When Using

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

When using this productDrowsiness may occuravoid alcoholic beveragesalcohol, sedatives, and tranquilizers may increase the drowsiness effect use caution when driving a motor vehicle or operating machineryexcitaility may occur, especially in children

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

Storage And Handling

Other information:Store at room temperature.

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

Store at 59 - 86  degree Fahrenheit (15 - 30 degree Celsius); Tamper-evident sealed packets. do not use any opened or torn packets Mfd. for MEDIQUE PRODUCTS, FORT MYERS, FL 33967

Store at room temperature. Tamper-evident sealed packets. do not use any opened or torn packets Mfd. for MEDIQUE PRODUCTS, FORT MYERS, FL 33967

Description

Made in CHINALOT/EXP:

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 CHINA20130301

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: 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

Ask a doctor before use if you have liver disease

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 you are:under a doctor's care for any serious condition;  taking any other drug

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin Stop using and ask a doctor if symptoms do not improvenew symptoms occurpain or fever persists or gets worseredness or swellign is present

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. 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.

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

Dosage & Administration

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.

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.

Adults and children: (12 years and older) take 2 tablets every 4 to 6 hours as needed. Do not take more than 8 tablets in 24 hours.Children under 12 years:do not give to children under 12 years of age.

Adults and children: (12 years and older) take 1 capsule every 4 to 6 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 unless directed by a doctor.

Inactive Ingredient

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 Ingredients:Cellulose*, corn starch*, crospovidone*, hydroxypropyl cellulose*, hypromellose*, magnesium stearate*, microcrystalline cellulose*, mineral oil*, opadry clear*, polyethylene glycol*, polyvinylpyrrolidone*, povidone*, pregelatinized starch*, propylene glycol*, silicon dioxide*, sodium carboxymethylcellulose*, sodium starch glycolate*, starch 1500*, stearic acid, talc*, titanium dioxide*, triacetin*.

Inactive Ingredients:DandC Red 28, FDandC Blue 1, FDandC Red 40, gelatin, starch

Inactive Ingredient:   Purified water

Indications & Usage

Uses   for the temporary relief of minor aches and pains associated with headache ; muscular aches ; minor arthritis pain ; toothache ; common cold ; menstrual cramps ; for the reduction of fever

Uses   Temporarily relieves the following symptoms associated with hay fever or other upper respiratory allergies:runny nose, sneezing, itching of the nose or throat, itchy, watery eyes

* Please review the disclaimer below.