Label: PROACTIV PLUS RETEXTURIZING TONER- salicylic acid cream
- NDC Code(s): 11410-051-00, 11410-051-05, 11410-051-10
- Packager: THE PROACTIV COMPANY 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 July 10, 2018
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- SPL UNCLASSIFIED SECTION
- Active ingredients
When using this product
- do not use this product more than three times per day.
- 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.
- cleanse the skin thoroughly before applying this product.
- cover the entire affected areas 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 use to once a day or every other day.
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 59 mL Carton
- PRINCIPAL DISPLAY PANEL - 59 mL Carton (Pads)
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
PROACTIV PLUS RETEXTURIZING TONER
salicylic acid cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11410-051 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 20 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Butylene Glycol (UNII: 3XUS85K0RA) HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V) GLYCOLIC ACID (UNII: 0WT12SX38S) SODIUM HYDROXIDE (UNII: 55X04QC32I) PURSLANE (UNII: M6S840WXG5) POLYSORBATE 20 (UNII: 7T1F30V5YH) EDETATE DISODIUM (UNII: 7FLD91C86K) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) SODIUM BENZOATE (UNII: OJ245FE5EU) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11410-051-00 1 in 1 CARTON 02/15/2014 1 59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:11410-051-05 1 in 1 CARTON 02/15/2014 2 59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 3 NDC:11410-051-10 180 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/15/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part333D 02/15/2014 Labeler - THE PROACTIV COMPANY LLC (080216357) Establishment Name Address ID/FEI Business Operations Vee Pak Inc. 874763303 MANUFACTURE(11410-051)