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AAFX Hair

Medically reviewed on January 26, 2018

Dosage form: solution
Ingredients: Allantoin 0.02mg
Labeler: Prostemics Co., Ltd.
NDC Code: 62041-100

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

ACTIVE INGREDIENT

Active Ingredient: Allantoin 0.50%

INACTIVE INGREDIENT

Inactive Ingredient:

Inactive Ingredient(Powder): sh-Oligopeptide-1, sh-Polypeptide-1, rh-Polypeptide-8, sh-Polypeptide-22, rh-Polypeptide-9, Niacinamide, Ascorbyl Glucoside, Linoleic acid, Mannitol

Inactive Ingredient(Solution): Water, Polyquaternium-7, Propylene Glycol, Glycerin, 1,2-Hexanediol, Glycyrrhiza Glabra (Licorice) Root Extract, Sophora Angustifolia Root Extract, Glycine Soja (Soybean) Seed Extract, Camellia Sinensis Leaf Extract, Angelica Gigas Root Extract, Panax Ginseng Root Extract, Cnidium Officinale Root Extract, Polygonum Multiflorum Root Extract, Niacinamide, Polysorbate 20, Lactic Acid, DISODIUM EDTA

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warnings:

1. In case of having following symptoms after using this product, stop using it immediately. If the symptoms get worse, you need to consult a dermatologist. 1) In case of having problems such as red spots, swelling, itching or irritation during using this product, 2) In case of having the same symptoms above on the part where you put this product, which is exposed to direct sunlight. 2. Do not use it on the part where you have a scar, eczema or dermatitis. 3. Topical use only

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children: Keep out of infants or children's reach.

INDICATIONS & USAGE

Indication and Usage:

1. Store in refrigerator at or below 6 degrees Celsius. 2. Do not put it in extremely hot or cold places or where exposed to direct sunlight.

DOSAGE & ADMINISTRATION

Dosage and Administration:

Gently mix AAFX Powder with AAFX Solution and apply to skin several times. Once opened and mixed, the formula must be used within 3 hours. Single Use Only.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

AAFX HAIR 
allantoin solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62041-100
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Allantoin (ALLANTOIN) Allantoin0.02 mg  in 7 
Inactive Ingredients
Ingredient NameStrength
Water 
Propylene Glycol 
Packaging
#Item CodePackage Description
1NDC:62041-100-017 SOLUTION in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34712/01/2014
Labeler - Prostemics Co., Ltd. (687768142)
Registrant - Prostemics Co., Ltd. (687768142)
Establishment
NameAddressID/FEIOperations
Prostemics Co., Ltd.687768142manufacture(62041-100)

 
Prostemics Co., Ltd.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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