AGE DEFYING BLEMISH TREATMENT- salicylic acid cream

Age Defying Blemish Treatment by

Drug Labeling and Warnings

Age Defying Blemish Treatment by is a Otc medication manufactured, distributed, or labeled by Wasatch Product Development, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

Clear

Age Defying Treatment

2% Salicylic Acid

Acne Treatment

4% Azelaic Acid

Skin Conditioner

30 ML/ 1 FL OZ

INGREDIENTS AND APPEARANCE

AGE DEFYING BLEMISH TREATMENT 
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 44717-148
Route of Administration	TOPICAL

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)