![RUGBY BENZOYL PEROXIDE ACNE MEDICATION (BENZOYL PEROXIDE) LOTION [RUGBY LABORATORIES, INC.]](https://medic.hrt.org//dailymed/images/460095b7-0e93-4179-877b-cc5f1b39fa0d/rugby-01.jpg)
- 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 frequent or in a lower concentration.
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Directions
- 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.
- Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 29.5 mL Tube Carton
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INGREDIENTS AND APPEARANCE
RUGBY BENZOYL PEROXIDE ACNE MEDICATION
benzoyl peroxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-1058 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 Carboxymethylcellulose Sodium, Unspecified Form (UNII: K679OBS311) Edetate Disodium (UNII: 7FLD91C86K) Laureth-4 (UNII: 6HQ855798J) Sodium Hydroxide (UNII: 55X04QC32I) Titanium Dioxide (UNII: 15FIX9V2JP) Water (UNII: 059QF0KO0R) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0536-1058-75 1 in 1 CARTON 01/20/2015 1 29.5 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 FINAL part333D 01/20/2015 Labeler - Rugby Laboratories, Inc. (079246066) Registrant - Garcoa, Inc. (036464697) Establishment Name Address ID/FEI Business Operations Sigan Industries, Inc. 255106239 MANUFACTURE(0536-1058)
