Label: CLEARASIL ULTRA ACNE CLEARING SCRUB- salicylic acid solution
- NDC Code(s): 63824-318-01
- Packager: RB Health (US) LLC
- 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 July 19, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Use
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Warnings
For external use only
When using this product
- avoid contact with the eyes. If product gets into the eyes rinse thoroughly with water.
- with other topical acne medications, at the same time or immediately following use of this product, increased dryness or irritation of the skin may occur. If this occurs, only one acne medication should be used unless directed by a doctor.
- limit use to the face and neck.
- Directions
- Other information
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Inactive ingredients
Water, Polyethylene, PPG-15 Stearyl Ether, Glycerin, Stearyl Alcohol, Cetyl Betaine, Distearyldimonium Chloride, Sodium Lauryl Sulfate, Cetyl Alcohol, Alcohol, Steareth-21, Sodium Chloride, Behenyl Alcohol, Synthetic Wax, Steareth-2, Fragrance, Xanthan Gum, Lavandula Stoechas Extract, Helichrysum Italicum Extract, Cistus Monspeliensis Extract, Lauryl Alcohol, Mica, Disodium EDTA, PEG-40 Hydrogenated Castor Oil, BHT, Magnesium Nitrate, Phenoxyethanol, Methylparaben, Methylchloroisothiazolinone, Magnesium Chloride, Butylparaben, Ethylparaben, Isobutylparaben, Propylparaben, Methylisothiazolinone, Ferric Ferrocyanide, Titanium Dioxide, Blue1.
- SPL UNCLASSIFIED SECTION
- Questions? Comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 150 mL Label
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INGREDIENTS AND APPEARANCE
CLEARASIL ULTRA ACNE CLEARING SCRUB
salicylic acid solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63824-318 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 WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) PPG-15 STEARYL ETHER (UNII: 1II18XLS1L) GLYCERIN (UNII: PDC6A3C0OX) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) CETYL BETAINE (UNII: E945X08YA9) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) SODIUM LAURYL SULFATE (UNII: 368GB5141J) CETYL ALCOHOL (UNII: 936JST6JCN) ALCOHOL (UNII: 3K9958V90M) STEARETH-21 (UNII: 53J3F32P58) SODIUM CHLORIDE (UNII: 451W47IQ8X) DOCOSANOL (UNII: 9G1OE216XY) STEARETH-2 (UNII: V56DFE46J5) XANTHAN GUM (UNII: TTV12P4NEE) LAURYL ALCOHOL (UNII: 178A96NLP2) MICA (UNII: V8A1AW0880) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) MAGNESIUM NITRATE (UNII: 77CBG3UN78) PHENOXYETHANOL (UNII: HIE492ZZ3T) METHYLPARABEN (UNII: A2I8C7HI9T) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) BUTYLPARABEN (UNII: 3QPI1U3FV8) ETHYLPARABEN (UNII: 14255EXE39) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) PROPYLPARABEN (UNII: Z8IX2SC1OH) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) FERRIC FERROCYANIDE (UNII: TLE294X33A) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63824-318-01 1 in 1 CARTON 08/18/2009 09/01/2024 1 150 mL in 1 BOTTLE; 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 08/18/2009 09/01/2024 Labeler - RB Health (US) LLC (081049410)