Label: OKAY FACIAL SCRUB- salicylic acid gel
- NDC Code(s): 74553-016-01
- Packager: Xtreme Tools International, Inc
- 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 September 9, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
- Purpose
- Use
- Warning
- When using this product
- KEEP OUT OF REACH OF CHILDREN
-
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
- QUESTIONS
- PACKAGE LABEL
-
INGREDIENTS AND APPEARANCE
OKAY FACIAL SCRUB
salicylic acid gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74553-016 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 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) Glycerin (UNII: PDC6A3C0OX) ACRYLATES CROSSPOLYMER-4 (UNII: GEV2EL4D9G) PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V) SODIUM HYDROXIDE (UNII: 55X04QC32I) PAPAYA (UNII: KU94FIY6JB) GUAVA (UNII: 74O70D6VG0) Panthenol (UNII: WV9CM0O67Z) SYNTHETIC WAX (1800 MW) (UNII: 248P1AUJ90) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:74553-016-01 170 g in 1 TUBE; Type 0: Not a Combination Product 09/11/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M006 09/11/2023 Labeler - Xtreme Tools International, Inc (125398904)