Active Ingredient
Active Ingredient:
Benzalkonium Chloride 0.40%
Easy Care First Aid - All Purpose
FDA Label NDC 44224-1999
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Tender Corp Dba Adventure Medical Kits for the product Easy Care First Aid - All Purpose (NDC 44224-1999). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, use, warnings, otc - keep out of reach of children, otc - stop use, otc - do not use, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiseptic
Triple Antibiotic
Purpose: First aid antiseptic, external analgesic
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
For external use only
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 if
you do not notice any signs or symptoms. Do not exceed recommended dosage
Keep out of reach of Children.
If ingested, 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 appearStop use and ask a doctor ifcondition worsenssymptoms persist for more than 7 dayscondition clears up and occurs again within a few days
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: In eyes, in large quantities, over raw blistered areas, or on deep puncture wounds, animal bites or serious burns, for more than one weekDo not use: in the eyes or apply over large areas of the body.longer than 1 week unless directed by a doctor.in large quantities, particularly over raw surfaces or blistered areas.Ask a doctor before use if you have deep puncture wounds, animal bites or serious burns.When using this product, avoid contact with the eyes.
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
Adults and children 2 years of age and older
clean affected area.
apply a small amount of this product on the area 1 to 3 times daily.
may be covered with a sterile bandage
children under 2 years of age: consult a doctor
Inactive Ingredients
Inactive Ingredient: Purified water
Aloe vera, cetyl alcohol, diazolidinyl urea, edetate disodium, glycerin, glyceryl monostearate, methylparaben, mineral oil, polyethylene glycol, propylene glycol, propylparaben, purified water, stearic acid, irolamine
Other
LOT/EXP: Made in CHINA
20130301
Package Label.Principal Display Panel
Antiseptic Towelette
Genuine First Aid LLC, Clearwater FL 33755
www.GenuineFirstAid.com
1/pouch
GENUINE FIRST AID
Insect Sting Relief 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.
Triple Antibiotic Ointment 10pcs
Net wt. 0.9g (1/32oz)
100
Triple Antibiotic
GENUINE FIRST AID 2 Tablets
NON-ASPIRIN
IBUPROFEN 2 Tablets
IBUPROFEN 2 Tablets
Genuine First Aid Burn Cream
Antiseptic Pain Relief With Aloe
Net Wt 0.9g (1/32 oz)
Manufactured in CHINA for
Genuine First Aid.
Burn Cream (Burncream)
Genuine Triple Antibiotic (Tripleantibiotic)
Non Aspirin (Non Aspirin)
Anitseptic Towelette (Towelette)
Insect Sting Relief Pad (Insectstingreliefpad)
Ibuprofen 200mg (Ibuprofen)
On The Go First Aid (Allpurpose)
Otc - Active Ingredient
Active Ingredient: Purpose:
Benzocaine, 6% w/v.................. Topical Anesthetic
SD alcohol, 60% w/v.................. Antiseptic
Active Ingredient (in each tablet) Purpose
Acetaminophen 325 mg ............. Analgesic/antipyretic
Active ingredient (in each tablet) Purpose
Ibuprofen 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.
Uses
temporary relief of minor aches and pains associated with:
common cold; headache; toothache; muscular aches; backache; arthritis; menstrual cramps; and reduction of 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 room temperature (do not freeze).
Taper evident sealed packets.
Do not use packet if opened or torn.
Description
Made in CHINA
LOT/EXP:
Distributed by GENUINE FIRST AID
600 Cleveland Str Suite 400, Clearwater, FL 33755
LOT/EXP: Made in CHINA
20130301
GFA Production Xiamen Co., Ltd
No. 20 Huli Industrial Park, Meixi Road, Tong'an, Xiamen, Fujian, China 361100
Tel: 86-592-7269515 Fax: 86-592-7269528 Http: //www.gfaproduction.com
Active Ingredients
Active Ingredient: .........Bacitracin Zinc 400 units
Neomycin Sulfate 5mg ( equivalent to 3.5 mg Neomycin base)
Polymyxin B Sulfate 5000 units
ACTIVE INGREDIENTS:
Benzalkonium Chloride 0.13%
Lidocaine HCL 0.5%
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
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Dosage & Administration
Directions
Adults and Children Take 2 tablets every 4 to 6 hours as
12 years of age needed. Do not take more than 12 tablets
or older in 24 hours.
Children 6-11 years Take 1 tablet every 4 to 6 hours as
of 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.
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
Uses
First aid to help prevent infection and for the temporary relief of pain and itching associated with:
Minor Cuts
Scrapes
Burns
* Please review the disclaimer below.
