Active Ingredient
Active Ingredient:
Benzalkonium Chloride 0.40%
One Prep pad saturated with a 10% Povidone-Iodine solution equivalent to 1% available iodine
Gfa First Aid
FDA Label NDC 52124-1167
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Genuine First Aid, Llc for the product Gfa First Aid (NDC 52124-1167). 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
Purpose: First aid antiseptic, external analgesic
Triple Antibiotic
antiseptic, germicidal
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.
For external use only
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 ingested, contact a Poison Control Center right away.
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
Otc - Do Not Use
Do not use in the eyes or over large areas of the body.
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.
Directions
Tear open packet, unfold towelette and use to cleanse desired skin area. Discard towelette appropriately after single use.
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
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
Clean intended area thoroughly with pad. Discard after single use.
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
Purified water.
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
Genuine First Aid Burn Cream
Antiseptic Pain Relief With Aloe
Net Wt 0.9g (1/32 oz)
Manufactured in CHINA for
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
Povidone-iodine Prep Pads (Poviodine)
Povidone-iodine Prep Pads (Poviodine10)
Genuine Triple Antibiotic (Tripleantibiotic)
Genuine Triple Antibiotic (Tripleantibiotic10)
Burn Cream (Burncream)
Burn Cream (Burncream6)
Antiseptic Towelette (Towelette)
Antiseptic Towelette (Towelette10)
Gfa First Aid Kit (Firstaid Kit36)
Gfa First Aid Kit (Firstaid Kit36 1)
Active Ingredients
ACTIVE INGREDIENTS:
Benzalkonium Chloride 0.13%
Lidocaine HCL 0.5%
Active Ingredient: .........Bacitracin Zinc 400 units
Neomycin Sulfate 5mg ( equivalent to 3.5 mg Neomycin base)
Polymyxin B Sulfate 5000 units
Uses
First aid to help prevent infection and for the temporary relief of pain and itching associated with:
Minor Cuts
Scrapes
Burns
Provides, antiseptic germicidal skin preperation for minor invasive procedures
Storage And Handling
Other Information:
Store at room temperature (do not freeze).
Taper evident sealed packets.
Do not use packet if opened or torn.
Other information:
Store at room temperature.
Description
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
Indications & Usage
Uses: To help prevent infection in:
minor cuts; scrapes; burns
Inactive Ingredient
Water
Keep Out Of Reach Of Children
For external use only.
Caution
In case of deep or puncture wounds or serious burns, and if pain, irritation, redness, swelling or infection occurs, discontinue use and contact a physician.
* Please review the disclaimer below.
