FDA Label for Adventure Medical Kits 1-4 Person First Aid
View Indications, Usage & Precautions
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- WARNINGS
- OTC - DO NOT USE
- OTC - STOP USE
- OTC - KEEP OUT OF REACH OF CHILDREN
- OTC - WHEN USING
- STORAGE AND HANDLING
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
- DESCRIPTION
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - PREGNANCY OR BREAST FEEDING
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- INDICATIONS & USAGE
Adventure Medical Kits 1-4 Person First Aid Product Label
The following document was submitted to the FDA by the labeler of this product Tender Corp Dba Adventure Medical Kits. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active Ingredient: .........Bacitracin Zinc 400 units
Neomycin Sulfate 5mg ( equivalent to 3.5 mg Neomycin base)
Polymyxin B Sulfate 5000 units
Active Ingredient: Purpose:
Benzocaine, 6% w/v.................. Topical Anesthetic
SD alcohol, 60% w/v.................. Antiseptic
Active ingredient (in each tablet) Purpose
Ibuprofen USP (NSAID*) 200mg . . . . . . . . . . . .Pain reliever/fever reducer
*nonsteroidal anti-inflammatory drug
Active Ingredient (in each tablet) Purpose
Aspirin (NSAID*) 325 mg............................... Pain Reliever / fever reducer
*nonsteroidal anti-inflammatory drug
Active Ingredient (in each tablet) Purpose
Acetaminophen 500 mg............................... Pain Reliever / fever reducer
Active Ingredient (in each tablet) Purpose
Diphenhydramine Hydrochloride 25mg............................... Antihistimine
Active Ingredient: Purpose
Benzalkonium 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 feverUses 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
Warnings
Reye'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
Liver 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 use
if you have:
a breathing problem such as emphysema or chronic bronchitis
glaucoma
difficulty in urination due to enlargement of the prostate gland
if 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; 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 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 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
Directions
do not use more than directed
the smallest effective dose should be used
drink a full glass of water with each dose
do not take longer than 10 days, unless directed by a doctor
When using this product
Drowsiness may occur
avoid alcoholic beverages
alcohol, sedatives, and tranquilizers may increase the drowsiness effect
use caution when driving a motor vehicle or operating machinery
excitaility 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.
Store at 59 - 86 degree Fahrenheit (15 - 30 degree Celsius); avoid
excessive 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
Package Label.Principal Display Panel
Genuine Triple Antibiotic
First Aid Ointment
To Help Prevent Infection
Each Gram Contains:
Bacitracin Zinc 400 units
Neomycin Sulfate 5 mg
(equivalent to 3.5 mg
Neomycin base)
Polymyxin B Sulfate 5000 units
Net Wt. 0.5g ; (1/64 oz)
Manufactured in CHINA for
GENUINE FIRST AID.
Insect Sting Relief Pad
Genuine First Aid LLC, Clearwater FL 33755
www.GenuineFirstAid.com
1/pouch
GENUINE FIRST AID
IBUPROFEN 2 Tablets
IBUPROFEN 2 Tablets
Antiseptic Towelette
Genuine First Aid LLC, Clearwater FL 33755
www.GenuineFirstAid.com
1/pouch
GENUINE FIRST AID
Description
Made in CHINA
LOT/EXP:
Distributed by GENUINE FIRST AID
600 Cleveland Str Suite 400, Clearwater, FL 33755
600 Clevelad Str Suite 400, Clearwater, FL 33755
LOT/EXP: Made in CHINA
20130301
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 improve
new symptoms occur
pain or fever persists or gets worse
redness 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 with
water 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.