ACNE MEDICATION 5- 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 5%

Purpose

Acne Treatment

Keep out of reach of children

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

Directions

Warning

For external use only

Dosage

Use twice daily or as directed by Physician.

Inactive Ingredients

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

Do not use if you

Uses

When using this product

Stop use and ask a doctor

If irritation becomes severe 

Other information

Store at room temperature 15 degrees to 30 degrees C (59 degrees to 86 degrees F)
For lot number and expiration date: See box or crimp of tube

Questions or comments?

 Call 1-800-645-2158

Principal display panel

Acne Medication 5

 

ACNE MEDICATION 5 
benzoyl peroxide gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-4089
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 50 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
EDETATE SODIUM (UNII: MP1J8420LU)  
STEARETH-30 (UNII: 5776GCL1DG)  
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
DIISOPROPANOLAMINE (UNII: 0W44HYL8T5)  
Product Characteristics
Color WHITE (Off-White) Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0536-4089-56 1 in 1 CARTON
1 42.5 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part333D 10/29/2012
Labeler - Rugby Laboratories (191427277)

Revised: 1/2013
Document Id: f3c1bcd1-625f-4a8f-807e-9d46edd216b0
Set id: 5c7e8253-d7cf-4935-8628-a7d69112ca7b
Version: 2
Effective Time: 20130115
 
Rugby Laboratories