Your browser does not support JavaScript! AGE DEFYING BLEMISH TREATMENT (SALICYLIC ACID) CREAM [WASATCH PRODUCT DEVELOPMENT, LLC]
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AGE DEFYING BLEMISH TREATMENT (salicylic acid) cream
[Wasatch Product Development, LLC]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Active Ingredient        Purpose

Salicylic Acid 2%          Acne Treatment

Uses

For the treatment of acne

Dries up acne pimples

Helps prevent new acne pimples

Keep out of reach of children. If swallowed, get medical help or contact a a Poison Control Center right away.

Stop use and ask a doctor if irritation becomes severe.

Warnings

For external use only

When using this product skin irritation and dryness is more likely to occur if you use another topical acne medication. If irritation occurs, start with one application daily, then gradually increase to two or three times daily if needed or directed by a doctor.

If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Directions

Clean the skin thoroughly before applying this product

Cover the entire affected area with a thin layer one to three times daily

Becuase excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three daily if needed or directed by a doctor. 

Inactive ingredients SD Alcohol 40-B, Ethoxydiglycol, Water, Glycerin, Azelaic Acid, Nylon-10/10, Polyacrylate Crosspolymer-6, Propanediol, Betaine, PEG-8/SMDI Copolymer, PEG-12 Dimethicone, Palmitoyl Tripeptide-38, Lens Esculenta (Lentil) Seed Extract, Tetrahexyldecyl Ascorbate, Dipotassium Glycyrrhizinate, Hydroxypropyl Cyclodextrin, Triethanolamine, Fragrance

Clear

Age Defying Treatment

2% Salicylic Acid

Acne Treatment

4% Azelaic Acid

Skin Conditioner

30 ML/ 1 FL OZ

carton label

bottle label

AGE DEFYING BLEMISH TREATMENT 
salicylic acid cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:44717-148
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
DIETHYLENE GLYCOL MONOETHYL ETHER 
WATER 
GLYCERIN 
AZELAIC ACID 
PROPANEDIOL 
BETAINE 
PEG-8/SMDI COPOLYMER 
PEG-12 DIMETHICONE (300 CST) 
LENTIL 
TETRAHEXYLDECYL ASCORBATE 
GLYCYRRHIZINATE DIPOTASSIUM 
HYDROXYPROPYL .ALPHA.-CYCLODEXTRIN 
TROLAMINE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:44717-148-021 in 1 CARTON
1NDC:44717-148-0130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H10/24/2013
Labeler - Wasatch Product Development, LLC (962452533)
Registrant - Wasatch Product Development, LLC (962452533)
Establishment
NameAddressID/FEIBusiness Operations
Wasatch Product Development, LLC962452533manufacture(44717-148)

Revised: 4/2014
 
Wasatch Product Development, LLC

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