Label: PROACTIV PLUS PORE TARGETING TREATMENT- benzoyl peroxide gel
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NDC Code(s):
11410-046-00,
11410-046-05,
11410-046-10,
11410-046-15, view more11410-046-20, 11410-046-25
- 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.
- Download DRUG LABEL INFO: PDF XML
- 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 the 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.
- 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
- 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 - 30 mL
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INGREDIENTS AND APPEARANCE
PROACTIV PLUS PORE TARGETING TREATMENT
benzoyl peroxide gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11410-046 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 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) GLYCERIN (UNII: PDC6A3C0OX) ALMOND OIL (UNII: 66YXD4DKO9) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POLYSORBATE 60 (UNII: CAL22UVI4M) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11410-046-05 1 in 1 BOX 01/03/2013 1 89 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 2 NDC:11410-046-00 1 in 1 BOX 01/03/2013 2 30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 3 NDC:11410-046-15 1 in 1 CARTON 08/01/2018 3 89 mL in 1 TUBE; Type 0: Not a Combination Product 4 NDC:11410-046-10 1 in 1 CARTON 08/01/2020 4 10 mL in 1 TUBE; Type 0: Not a Combination Product 5 NDC:11410-046-20 1 in 1 CARTON 12/01/2020 5 30 mL in 1 TUBE; Type 0: Not a Combination Product 6 NDC:11410-046-25 89 mL in 1 TUBE; Type 0: Not a Combination Product 07/15/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M006 01/03/2013 Labeler - Alchemee, LLC (080216357) Establishment Name Address ID/FEI Business Operations VEE PAK, LLC 874763303 manufacture(11410-046) Establishment Name Address ID/FEI Business Operations Apex International Mfg LLC 079110793 manufacture(11410-046)
