Label: RUGBY BENZOYL PEROXIDE WASH ACNE MEDICATION- benzoyl peroxide lotion
- NDC Code(s): 0536-1261-63
- Packager: Rugby Laboratories
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated February 13, 2024
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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
- avoid unnecessary sun exposure and use a sunscreen
- avoid contact with eyes, lips and mouth
- avoid contact with hair or 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.
- 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.
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Directions
- shake well
- Wet area to be cleansed
- Sensitive 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 directions stated below
- one to three times daily, wet skin and cover the entire affected area with a thin layer, liberally applying to areas to be cleansed. Massage gently into skin for 10-20 seconds working into a full lather, rinse thoroughly and pat dry
- 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.
- Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 148 mL Bottle Label
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INGREDIENTS AND APPEARANCE
RUGBY BENZOYL PEROXIDE WASH ACNE MEDICATION
benzoyl peroxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-1261 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide 100 mg in 1 mL Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) Cetyl Alcohol (UNII: 936JST6JCN) Edetate Disodium (UNII: 7FLD91C86K) Disodium Laureth Sulfosuccinate (UNII: D6DH1DTN7E) Glycerin (UNII: PDC6A3C0OX) Glyceryl Monostearate (UNII: 230OU9XXE4) Laureth-7 (UNII: Z95S6G8201) Magnesium Aluminum Silicate (UNII: 6M3P64V0NC) PEG-100 Stearate (UNII: YD01N1999R) Propylene Glycol (UNII: 6DC9Q167V3) Sodium Coco-Sulfate (UNII: 3599J29ANH) Sodium Lauroamphoacetate (UNII: SLK428451L) Water (UNII: 059QF0KO0R) Xanthan Gum (UNII: TTV12P4NEE) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0536-1261-63 148 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 12/17/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph drug M006 12/17/2019 Labeler - Rugby Laboratories (079246066) Registrant - Garcoa, Inc. (036464697) Establishment Name Address ID/FEI Business Operations Sigan Industries, Inc. 255106239 MANUFACTURE(0536-1261)
