SA OIL FREE SERUM- salicylic acid serum gel

SA Oil Free Serum by

Drug Labeling and Warnings

SA Oil Free Serum by is a Otc medication manufactured, distributed, or labeled by Essay Cosmetics Group, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Active Ingredient 1.2% Salicylic Acid

Purpose

Acne Medication

INDICATIONS & USAGE

■ apply evenly to the affected area one to two times daily

Directions

■ clean the skin thoroughly before applying this product ■ cover the entire affected area with a thin layer one to three times daily ■ because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor ■ if bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Inactive ingredients

Inactive ingredients Water, PEG-7 Glyceryl Cocoate, Propanediol, Glycerin, PEG-40 Hydrogenated Castor Oil, Cocamidopropyl dimethylamine, Glycine Betaine, Dipotassium Glycyrrhizinate, Bisabolol, Allantoin, Xanthan Gum, Hydroxyethylcellulose, Sodium Gluconate, Propylene Glycol, Diazolidinyl Urea, Lodopropynyl Butylcarbamate, Sodium Hydroxide

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

■ clean the skin thoroughly before applying this product ■ cover the entire affected area with a thin layer one to three times daily ■ because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor ■ if bothersome dryness or pealing occurs, reduce application to once a day or every other day

WARNINGS

Warnings ■ skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time ■ if irritation occurs, only use one topical acne medication at a time

.

Principal Display Panel

INGREDIENTS AND APPEARANCE

SA OIL FREE SERUM 
salicylic acid serum gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72900-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.72 g  in 0.72 g

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
COCAMIDOPROPYL DIMETHYLAMINE (UNII: L36BM7DG2T)
SODIUM GLUCONATE (UNII: R6Q3791S76)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
BETAINE (UNII: 3SCV180C9W)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
PROPANEDIOL (UNII: 5965N8W85T)
ALLANTOIN (UNII: 344S277G0Z)
XANTHAN GUM (UNII: TTV12P4NEE)
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72900-008-80	0.72 g in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	02/28/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	02/28/2019

Labeler - Essay Cosmetics Group, LLC (085448126)