Label: PROACTIV ACNE BODY BAR- salicylic acid soap
- NDC Code(s): 11410-400-00
- Packager: ALCHEMEE, 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.
Updated March 25, 2022
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- SPL UNCLASSIFIED SECTION
- Active ingredient
For external use only
When using this product
- skin irritation and dryness are 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.
- 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.
- cover the entire affected area with a thin layer and rinse thoroughly one to three times daily.
- because excessive drying of the skin may occur, start with one application daily, then gradually increase to two 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 - 127 g Bar Carton
INGREDIENTS AND APPEARANCE
PROACTIV ACNE BODY BAR
salicylic acid soap
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11410-400 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 mg in 100 g Inactive Ingredients Ingredient Name Strength Sodium Palmate (UNII: S0A6004K3Z) Sodium Palm Kernelate (UNII: 6H91L1NXTW) Water (UNII: 059QF0KO0R) Glycerin (UNII: PDC6A3C0OX) Palm Acid (UNII: B6G0Y5Z616) Titanium Dioxide (UNII: 15FIX9V2JP) Bambusa Bambos Stem (UNII: NRA4497HC5) Palm Kernel Acid (UNII: 79P21R4317) Jojoba Oil (UNII: 724GKU717M) Green Tea Leaf (UNII: W2ZU1RY8B0) Opuntia Ficus-Indica Seed Oil (UNII: 1XGW49AK2J) Sodium Chloride (UNII: 451W47IQ8X) Sodium Gluconate (UNII: R6Q3791S76) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11410-400-00 1 in 1 CARTON 06/01/2022 1 127 g 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 FINAL part333D 06/01/2022 Labeler - ALCHEMEE, LLC (080216357) Establishment Name Address ID/FEI Business Operations Twincraft Inc 093248870 manufacture(11410-400)