RUGBY BENZOYL PEROXIDE ACNE MEDICATION- benzoyl peroxide gel
NuCare Pharmaceuticals,Inc.

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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Rugby ® 10% Benzoyl Peroxide Gel

Drug Facts

Active ingredient

Benzoyl peroxide 10%

Purpose

Acne medication

Use

for the treatment of acne

Warnings

For external use only

Do not use this medication if you have very sensitive skin or if you are sensitive to benzoyl peroxide.

When using this product

n keep away from eyes, lips and mouth

avoid unnecessary sun exposure and use a sunscreen
avoid contact with hair or dyed fabric, including carpet and clothing which may be bleached by this product
skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Mild irritation may be reduced by using the product less frequently or in a lower concentration. If irritation becomes severe, discontinue use; if irritation still continues, consult a doctor.
using other topical acne medication at the same time or immediately following the use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Avoid contact with the eyes. If contact occurs, flush thoroughly with water.

Directions

Cleanse skin thoroughly before applying medication. Cover the entire affected area with a thin layer 1-3 times daily. If bothersome dryness or peeling occurs, reduce application to once a day.

Other information

Keep tightly closed. Avoid storing at extreme temperatures (below 40° F and above 100° F).

Inactive ingredients

carbomer, disodium EDTA, hydroxypropyl methylcellulose, laureth-4, sodium hydroxide, water

Questions or comments?

1-800-645-2158

Distributed by:
Rugby Laboratories
31778 Enterprise Drive
Livonia, MI 48150

PRINCIPAL DISPLAY PANEL - 42.5 g

pdp

RUGBY BENZOYL PEROXIDE ACNE MEDICATION
benzoyl peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68071-4069(NDC:0536-1056)
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	100 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
CARBOXYMETHYLCELLULOSE SODIUM (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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68071-4069-1	42.5 mL in 1 BOX; Type 0: Not a Combination Product	08/28/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333D	01/20/2015	12/31/2019

Labeler - NuCare Pharmaceuticals,Inc. (010632300)

Name	Address	ID/FEI	Business Operations
Establishment
NuCare Pharmaceuticals,Inc.		010632300	relabel(68071-4069)

Revised: 5/2020

Document Id: a64348cd-80c9-f19d-e053-2a95a90a9c9c

Set id: 57d83d13-1925-d0ba-e053-2991aa0abfb5

Version: 2

Effective Time: 20200522

NuCare Pharmaceuticals,Inc.