SA OIL FREE CREAM- salicylic acid cream cream

SA Oil Free Cream by

Drug Labeling and Warnings

SA Oil Free Cream 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

Acne medication, 1% Salicylic Acid

PURPOSE

Acne Medication

Use

Use ■ for treatmant of acne

WARNINGS

Warnings ■ for external use only ■ 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

INSTRUCTIONS FOR USE

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 INGREDIENT

Inactive ingredients Water, Glycerin, Dimethicone, Cetyl Alcohol, Propanediol, Isopropyl Myristate, Glyceryl Stearate, PEG-100 Stearate, Behentrimonium Methosulfate, Bisabolol, Cyclomethicone, Allantoin, Butylene Glycol, Tocopheryl Acetate, Propylene Glycol, Disodium EDTA, Diazolidinyl Urea, Iodopropynyl Butylcarbamate

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

● 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.

Principal Display Panel

INGREDIENTS AND APPEARANCE

SA OIL FREE CREAM 
salicylic acid cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72900-882
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.5 g  in 0.5 g

Inactive Ingredients
Ingredient Name	Strength
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
DIMETHICONE 350 (UNII: 2Y53S6ATLU)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
PEG-100 STEARATE (UNII: YD01N1999R)
BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)
CYCLOMETHICONE (UNII: NMQ347994Z)
ALLANTOIN (UNII: 344S277G0Z)
.ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)
1,2-PROPANEDIOL, 1-BENZOATE (UNII: K4K90ZQ89N)
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
WATER (UNII: 059QF0KO0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
PROPANEDIOL (UNII: 5965N8W85T)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72900-882-70	0.5 g in 1 BOTTLE, PUMP; 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)