FDA Label for Genuine First Aid - Auto First Aid
View Indications, Usage & Precautions
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- WARNINGS
- STORAGE AND HANDLING
- OTC - DO NOT USE
- OTC - STOP USE
- OTC - KEEP OUT OF REACH OF CHILDREN
- OTC - WHEN USING
- INACTIVE INGREDIENT
- DESCRIPTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - PREGNANCY OR BREAST FEEDING
- DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
Genuine First Aid - Auto First Aid Product Label
The following document was submitted to the FDA by the labeler of this product Genuine First Aid, Llc. 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: Purpose
Isopropyl Alcohol, 70% v/v............... Antiseptic
Active Ingredient: .........Bacitracin Zinc 400 units
Neomycin Sulfate 5mg ( equivalent to 3.5 mg Neomycin base)
Polymyxin B Sulfate 5000 units
Active ingredient (in each tablet) Purpose
Ibuprofen USP (NSAID*) 200mg . . . . . . . . . . . .Pain reliever/fever reducer
*nonsteroidal anti-inflammatory drug
Active Ingredient (in each tablet) Purpose
Acetaminophen 500 mg............................... Pain Reliever / fever reducer
Active Ingredient: Purpose
Benzalkonium Chloride 0.40%.......... First Aid Antiseptic
Otc - Purpose
Use: For preparation of skin before injection.
Uses: To help prevent infection in:
minor cuts; scrapes; burns
Purpose: Pain reliever, fever reducer
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.
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. 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.
Warning: For external use only.
Storage And Handling
Flammable - keep away from fire or flame
Store at room temperature 15-30 degree Celsius (59-86 degree Fahrenheit)
Other information:
Store at room temperature.
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
Otc - Do Not Use
Do not use: with electrocautery, in the eyes.
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 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 if irritation and redness develop. If condition persists for more than 72 hours, consult your doctor.
Stop use and consult a doctor:
if the condition persists or gets worse; a rash or other allergic reaction develops
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 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, 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
Keep out of reach of children: If swallowed, get medical help or contact a Poison Control Center right away.
Otc - When Using
Wipe Injection site vigorously and discard.
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
Directions: Tear open packet, unfold towelette and use to cleanse desired skin area. Discard towelette appropriately after single use.
Inactive Ingredient
Inactive Ingredient: Purified 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.
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 Ingredient: Purified water
Description
LOT/EXP: Made in CHINA
20140301
Distributed by GENUINE FIRST AID
600 Cleveland Str Suite 400, Clearwater, FL 33755
LOT/EXP: Made in CHINA
20130301
Package Label.Principal Display Panel
Alcohol Cleansing Pad
Genuine First Aid LLC, Clearwater FL 33755
www.GenuineFirstAid.com
1/pouch
GENUINE FIRST AID
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.
IBUPROFEN 2 Tablets
IBUPROFEN 2 Tablets
Antiseptic Towelette
Genuine First Aid LLC, Clearwater FL 33755
www.GenuineFirstAid.com
1/pouch
GENUINE FIRST AID
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 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 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.
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 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.
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
* Please review the disclaimer below.