Label: CLEARASIL ULTRA OVERNIGHT FACE- salicylic acid lotion
- NDC Code(s): 63824-339-01
- 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)
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- 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 your doctor
- Limit use to the face and neck
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Directions
- Cleanse the skin thoroughly before applying medication
- 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 2 or 3 applications 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 information
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Inactive ingredients
Water, Butylene Glycol, Octyldodecanol, Steareth-2, Cetyl Alcohol, Steareth-21, Dimethicone, Polyacrylamide Glycerin, C13-14 Isoparaffin, Phenoxyethanol, Sodium Hydroxide, Xanthan Gum, Magnesium Aluminum Silicate, Laureth-7, Fragrance, Lavandula Stoechas Extract, Helichrysum Italicum Extract, Cistus Monspeliensis Extract, Methylparaben, Butylparaben, Ethylparaben, Isobutylparaben, Propylparaben, Titanium Dioxide
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- PRINCIPAL DISPLAY PANEL - 38.4 mL Tube Carton
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INGREDIENTS AND APPEARANCE
CLEARASIL ULTRA OVERNIGHT FACE
salicylic acid lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63824-339 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) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) OCTYLDODECANOL (UNII: 461N1O614Y) STEARETH-2 (UNII: V56DFE46J5) CETYL ALCOHOL (UNII: 936JST6JCN) STEARETH-21 (UNII: 53J3F32P58) DIMETHICONE (UNII: 92RU3N3Y1O) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM HYDROXIDE (UNII: 55X04QC32I) XANTHAN GUM (UNII: TTV12P4NEE) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) LAURETH-7 (UNII: Z95S6G8201) LAVANDULA STOECHAS FLOWERING TOP (UNII: 70759G2U6A) HELICHRYSUM ITALICUM FLOWER OIL (UNII: O97ZV7726K) METHYLPARABEN (UNII: A2I8C7HI9T) BUTYLPARABEN (UNII: 3QPI1U3FV8) ETHYLPARABEN (UNII: 14255EXE39) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) PROPYLPARABEN (UNII: Z8IX2SC1OH) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63824-339-01 38.4 mL in 1 TUBE; Type 0: Not a Combination Product 08/18/2011 09/01/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 08/18/2011 09/01/2024 Labeler - RB Health (US) LLC (081049410)
