Label: PROACTIV CLEAR ZONE BODY PADS- salicylic acid liquid
- NDC Code(s): 11410-056-00, 11410-056-05
- Packager: Alchemee, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 28, 2023
If you are a consumer or patient please visit this version.
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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- 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.
- avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
- Keep out of reach of children.
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Directions
- Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below.
- clean the skin thoroughly before applying this product
- gently wipe the entire affected area with the pad 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 or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PROACTIV CLEAR ZONE BODY PADS
salicylic acid liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11410-056 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 ALCOHOL (UNII: 3K9958V90M) ALLANTOIN (UNII: 344S277G0Z) AMMONIA (UNII: 5138Q19F1X) GREEN TEA LEAF (UNII: W2ZU1RY8B0) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) GLYCOLIC ACID (UNII: 0WT12SX38S) HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY) IMIDUREA (UNII: M629807ATL) PANTHENOL (UNII: WV9CM0O67Z) POLYSORBATE 20 (UNII: 7T1F30V5YH) SODIUM BENZOATE (UNII: OJ245FE5EU) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11410-056-00 75 in 1 JAR 01/03/2017 1 2 mL in 1 APPLICATOR; Type 0: Not a Combination Product 2 NDC:11410-056-05 30 in 1 JAR 01/01/2020 2 1 mL in 1 APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M006 01/03/2017 Labeler - Alchemee, LLC (080216357) Establishment Name Address ID/FEI Business Operations Topiderm Inc. 049121643 manufacture(11410-056)
