Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

ACNE MEDICATION 10- benzoyl peroxide gel 
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 10%

Purpose

Acne treatment

Uses

• treats acne
• dries up acne pimples
• helps prevent new acne pimples

Warnings

For external use only

Do not use

• if you have sensitive skin or are sensitive to benzoly peroxide

When using this product

• apply to affected ares only
• avoid unnecessary sun exposure and use a sunscreen
• avoid contact with the eyes, lips and mouth
• this product may bleach hair or dyed fabrics
• with other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. Only one medication should be used unlee directed by a physician
• skin irritaion may occur characterized by redness, burning, itching, peeling or possible swelling

Stop and ask a doctor if

• irritation becomes severe

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

• clean the skin thoroughly before applying
• cover the entire affected area with a thin layer 1 to 3 times daily
• because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 to 3 times daily if needed or as directed by a doctor.
• If bothersome dryness or peeling occurs, reduce application ot once a day or every other day.
• if going outside, use a sunscreen. Allow benzoyl peroxide to dry, then follow directions in the sunscreen labeling.
• Sensitivity Test for 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 above.

Other information

• store at room temperature 15 degrees to 30 degrees C (59 degrees to 86 degrees F)
• Lot number & expiration date: See box or crimp of the tube

Inactive ingredients

Brij 30, carbomer, diisopropanolamine, edetate sodium, Purified water

Principal display panel

10% Benzoyl Peroxide Gel

ACNE MEDICATION 10 
benzoyl peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-4092
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 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
STEARETH-30 (UNII: 5776GCL1DG)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
DIISOPROPANOLAMINE (UNII: 0W44HYL8T5)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-4092-56	1 in 1 CARTON	10/29/2012	04/30/2018
1		42.5 g 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	10/29/2012	04/30/2018

Labeler - Rugby Laboratories (079246066)

Revised: 9/2019

Document Id: deb2eda1-42bd-4c73-87c0-e6adf53894c3

34390-5

Set id: 18e83482-f792-49c4-9faa-f26521832cf2

Version: 4

Effective Time: 20190906