Label: ACNE OIL CONTROL PRIMER- salicylic acid liquid
- NDC Code(s): 62742-4211-1, 62742-4211-2
- Packager: Allure Labs
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated April 1, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
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
- OTHER SAFETY INFORMATION
-
INACTIVE INGREDIENT
Inactive Ingredients
Water (Aqua), Dimethicone,
Butylene Glycol, Dimethicone
Crosspolymer, Ammonium
Polyacryloyldimethyl Taurate,
Hydroxyethylcellulose,
Serenoa Serrulata (Saw
Palmetto) Fruit Extract,
Sodium Ascorbyl Phosphate,
Niacinamide, Linoleic Acid,
Linolenic Acid,
Docosahexaenoic Acid,
Eicosapentaenoic Acid,
Nigella Sativa (Black Cumin)
Seed Oil, Scutellaria
Baicalensis Root Extract, Zinc
Gluconate, Glycerin,
Tocopherol, Oleanolic Acid,
Enantia Chlorantha Bark
Extract, Caprylyl Glycol,
Ethylhexylglycerin, Hexylene
Glycol, Disodium Phosphate,
Phenoxyethanol, Polysorbate
60, Sodium Hydroxide,
Sodium Phosphate.
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ACNE OIL CONTROL PRIMER
salicylic acid liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62742-4211 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 20 mg in 1 g Inactive Ingredients Ingredient Name Strength SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S) ANNICKIA CHLORANTHA BARK (UNII: H70115MP4A) PHENOXYETHANOL (UNII: HIE492ZZ3T) AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S) (UNII: F01RIY4371) SAW PALMETTO (UNII: J7WWH9M8QS) NIACINAMIDE (UNII: 25X51I8RD4) DOCONEXENT (UNII: ZAD9OKH9JC) NIGELLA SATIVA SEED OIL (UNII: CS4U38E731) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) LINOLENIC ACID (UNII: 0RBV727H71) ZINC GLUCONATE (UNII: U6WSN5SQ1Z) TOCOPHEROL (UNII: R0ZB2556P8) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) POLYSORBATE 60 (UNII: CAL22UVI4M) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) SODIUM HYDROXIDE (UNII: 55X04QC32I) ICOSAPENT (UNII: AAN7QOV9EA) GLYCERIN (UNII: PDC6A3C0OX) OLEANOLIC ACID (UNII: 6SMK8R7TGJ) HEXYLENE GLYCOL (UNII: KEH0A3F75J) HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D) LINOLEIC ACID (UNII: 9KJL21T0QJ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62742-4211-2 1 in 1 CARTON 04/01/2022 1 NDC:62742-4211-1 45 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 04/01/2022 Labeler - Allure Labs (926831603) Registrant - Allure Labs (926831603) Establishment Name Address ID/FEI Business Operations Allure Labs 926831603 manufacture(62742-4211)
