AGE DEFYING BLEMISH TREATMENT- salicylic acid cream 
Wasatch Product Development, LLC

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.

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Clear Age Defying Blemish Treatment

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 Type HUMAN OTC DRUG Item Code (Source) NDC:44717-148
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 2 g  in 100 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL (UNII: 3K9958V90M)  
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
AZELAIC ACID (UNII: F2VW3D43YT)  
PROPANEDIOL (UNII: 5965N8W85T)  
BETAINE (UNII: 3SCV180C9W)  
PEG-8/SMDI COPOLYMER (UNII: CCX72L6NY6)  
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
LENTIL (UNII: 6O38V6B52O)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
HYDROXYPROPYL .ALPHA.-CYCLODEXTRIN (UNII: ZFR0T80O4Y)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:44717-148-02 1 in 1 CARTON
1 NDC:44717-148-01 30 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part358H 10/24/2013
Labeler - Wasatch Product Development, LLC (962452533)
Registrant - Wasatch Product Development, LLC (962452533)
Establishment
Name Address ID/FEI Business Operations
Wasatch Product Development, LLC 962452533 manufacture(44717-148)

Revised: 2/2015
Document Id: 8d3fe2c3-2205-4bf6-aedc-c90d2b27d938
Set id: 675b60c8-573f-4863-9406-cd6caa11a2d1
Version: 4
Effective Time: 20150212
 
Wasatch Product Development, LLC