Label: CETAPHIL GENTLE CLEAR TRIPLE-ACTION ACNE SERUM- salicylic acid solution
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- NDC Code(s): 0299-4135-00, 0299-4135-05
- Packager: Galderma Laboratories, L.P.
- 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 27, 2022
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- Active Ingredients
- Purpose
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Warnings
For external use only.
When using this product
■ 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 treatment at a time. ■ avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.Stop use and ask a doctor if
■ irritation becomes severe - KEEP OUT OF REACH OF CHILDREN
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Directions
•Sensitivity Test for New User: Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow directions stated below. • 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
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INGREDIENTS AND APPEARANCE
CETAPHIL GENTLE CLEAR TRIPLE-ACTION ACNE SERUM
salicylic acid solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0299-4135 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid 5 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Glycerin (UNII: PDC6A3C0OX) Coco-Caprylate/Caprate (UNII: 8D9H4QU99H) Gluconolactone (UNII: WQ29KQ9POT) Propanediol (UNII: 5965N8W85T) Sodium Hydroxide (UNII: 55X04QC32I) Succinic Acid (UNII: AB6MNQ6J6L) Panthenol (UNII: WV9CM0O67Z) Niacinamide (UNII: 25X51I8RD4) Lysophosphatidylcholine, Soybean (UNII: CQD833204Z) Betasizofiran (UNII: 2X51AD1X3T) Zinc Gluconate (UNII: U6WSN5SQ1Z) Pullulan (UNII: 8ZQ0AYU1TT) Xanthan Gum (UNII: TTV12P4NEE) Pantolactone, (R)- (UNII: J288D7O0JS) Citric Acid Monohydrate (UNII: 2968PHW8QP) Silicon Dioxide (UNII: ETJ7Z6XBU4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0299-4135-00 1 in 1 CARTON 05/01/2022 1 30 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:0299-4135-05 5 mL in 1 TUBE; Type 0: Not a Combination Product 05/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 05/01/2022 Labeler - Galderma Laboratories, L.P. (047350186) Establishment Name Address ID/FEI Business Operations Fruit of The Earth, Inc. 080086802 manufacture(0299-4135)
