Label: CLEARASIL STUBBORN ACNE CONTROL 5IN1 EXFOLIATING WASH- salicylic acid lotion
- NDC Code(s): 63824-436-01
- 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 January 12, 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.
- 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.
- limit use to the face and neck
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Directions
- wet face
- dispense product into hands, lather and massage gently onto face and neck, avoiding the delicate eye area
- rinse thoroughly with warm water one too 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 information
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Inactive ingredients
Water, PPG-15 Stearyl Ether, Hydrated Silica, Glycerin, Stearyl Alcohol, Cetyl Betaine, Distearyldimonium Chloride, Sodium Lauryl Sulfate, Cetyl Alcohol, Alcohol Denat., Steareth-21, Sodium Chloride, Behenyl Alcohol, Synthetic Wax, Steareth-2, Xanthan Gum, Fragrance, Dimethyl Palmitamine, Lauryl Alcohol, Sodium Sulfate, Mica, Citric Acid, Disodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Lavandula Stoechas Extract, Helicrysum Italicum Extract, Cistus Monspeliensis Extract, Ferric Ferrocyanide, Titanium Dioxide, Blue 1
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 200 mL Tube Label
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INGREDIENTS AND APPEARANCE
CLEARASIL STUBBORN ACNE CONTROL 5IN1 EXFOLIATING WASH
salicylic acid lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63824-436 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) PPG-15 STEARYL ETHER (UNII: 1II18XLS1L) HYDRATED SILICA (UNII: Y6O7T4G8P9) 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) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) ISOPROPYL ALCOHOL (UNII: ND2M416302) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) HELICHRYSUM ITALICUM FLOWER (UNII: P62Y550X24) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) MICA (UNII: V8A1AW0880) 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:63824-436-01 200 mL in 1 TUBE; Type 0: Not a Combination Product 12/05/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 12/05/2017 Labeler - RB Health (US) LLC (081049410)
