Label: PROACTIVPLUS SKIN SMOOTHING EXFOLIATOR- benzoyl peroxide lotion
- NDC Code(s): 11410-011-68, 11410-011-82
- Packager: Alchemee, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 29, 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 unnecessary sun exposure and use a sunscreen
- avoid contact with eyes, lips and mouth
- avoid contact with hair and dyed fabrics, which may be bleached by this product
- skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.
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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.
- cover the entire affected area with a thin layer and rinse thoroughlyone 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
- if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 60 mL Carton
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INGREDIENTS AND APPEARANCE
PROACTIVPLUS SKIN SMOOTHING EXFOLIATOR
benzoyl peroxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11410-011 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 2.5 mg in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493) GLYCERIN (UNII: PDC6A3C0OX) LAURYL/MYRISTYL BENZOATE (UNII: N5RS934G6D) COCONUT ACID (UNII: 40U37V505D) LINOLEIC ACID (UNII: 9KJL21T0QJ) LINOLENIC ACID (UNII: 0RBV727H71) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DIMETHICONE (UNII: 92RU3N3Y1O) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) GLYCOLIC ACID (UNII: 0WT12SX38S) SODIUM ISETHIONATE (UNII: 3R36J71C17) SODIUM HYDROXIDE (UNII: 55X04QC32I) PHENOXYETHANOL (UNII: HIE492ZZ3T) PARAFFIN (UNII: I9O0E3H2ZE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11410-011-68 1 in 1 BOX 01/25/2013 1 177.4 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:11410-011-82 1 in 1 BOX 01/25/2013 2 60 mL in 1 TUBE; 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 01/25/2013 Labeler - Alchemee, LLC (080216357) Establishment Name Address ID/FEI Business Operations Vee Pak, LLC dba Voyant Beauty 874763303 manufacture(11410-011) Establishment Name Address ID/FEI Business Operations Apex International Mfg LLC 079110793 manufacture(11410-011)
