Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

ACNE MEDICATION 10- benzoyl peroxide lotion 
Rugby Laboratories

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.

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Drug Facts

Active ingredient

BENZOYL PEROXIDE

Purpose

Acne Treatment

Keep Out of Reach of Children

Keep out of reach of children.

If swallowed, get medical help or contact Poison Control Center right away.

Uses

treats acne

dries up acne pimples

helps prevent new acne pimples

Warnings

For external use only

Do not use:

if you have very sensitive skin or if you are sensitive to benzoyl peroxide.

Directions

shake well

clean the skin thoroughly before applying this product

cover 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 gradual increase to two three times daily 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 use sunscreen after using this product.

if irritation or sensitivity develops, discontinue use of both products and consult a doctor.

Sensitivity Test for New Users: Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occrs, follow the directions stated above

Inactive Ingredients

purified water, brij 30, carbomer, diisopropanolamine, disodium edetate

Other Safety Information

Other Information

to prevent bleaching, avoid contact with hair or dyed fabric and clothing

KEEP TIGHTLY CLOSE

store at room temperature 15°-30°C (59°-86°F)

Lot No. & Exp. Date: See box or bottle

Distributed by:

Rugby Laboratories

Livonia, MI 48150 USA

Questions?

Call 1-(800) 645-2158

Principal Display Panel

NDC: 0536-0815-95

BENZOYL PEROXIDE 10%

FOR TOPICAL USE

ACNE MEDICATION 10 
benzoyl peroxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-0815
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 1000 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC)
STEARETH-30 (UNII: 5776GCL1DG)
DIISOPROPANOLAMINE (UNII: 0W44HYL8T5)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-0815-95	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/29/2012	04/30/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	10/29/2012	04/30/2018

Labeler - Rugby Laboratories (079246066)

Revised: 9/2019

Document Id: cf952e90-d0b7-4cbc-99cb-ce791f8e551f

34390-5

Set id: e4680a46-a8e3-40e5-a491-f45de77382a9

Version: 2

Effective Time: 20190920