MICRONIZED BENZOYL PEROXIDE TREATMENT- benzoyl peroxide gel 
Pharmco Laboratories 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.

----------

Micronized Benzoyl Peroxide Treatment 5%

Drug Facts

Active Ingredient

Benzoyl Peroxide 5%

Purpose

Acne Treatment

Warnings

Do not use if you

  • Have very sensitive skin
  • Are sensitive to benzoyl peroxide

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 frequently or in a lower concentration.
  • If going outside, apply sunscreen after using this product.

  • If sensitivity develops or irritation becomes severe, stop use and ask a doctor.

  • Keep out of reach of children
  • If swallowed get medical help or call a poison control center immediately

  • Keep away from excessive heat or heat sources

Directions

Other Ingredients

Carbomer, Edetate Disodium, Glycerine, Propylene Glycol, Saccharide Isomerate, Sodium Hydroxide, Water.

Other Information

Store at 20 - 25°C (68 - 77°F) Protect from heat. Keep container tightly closed.

Manufactured by:
Pharmco Laboratories Inc. • Titusville, FL 32780
www.pharmcolabs.com • 1.800.635.0712 • Reorder CPL79-2

PRINCIPAL DISPLAY PANEL - 59 g Tube Label

PHARMCO
SKINCARE LABS

Micronized
Benzoyl
Peroxide
Treatment
5%

Net wt. 2 oz. (59 g)

Principal Display Panel - 59 g Tube Label
MICRONIZED BENZOYL PEROXIDE TREATMENT 
benzoyl peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58400-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Edetate Disodium (UNII: 7FLD91C86K)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Saccharide Isomerate (UNII: W8K377W98I)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58400-002-0159 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:58400-002-023900 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D06/01/2012
Labeler - Pharmco Laboratories Inc. (096270814)
Establishment
NameAddressID/FEIBusiness Operations
Pharmco Laboratories Inc.096270814MANUFACTURE(58400-002) , LABEL(58400-002) , PACK(58400-002) , ANALYSIS(58400-002)

Revised: 2/2015
Document Id: 808d5869-24f5-4545-81cc-a4ea719e6601
Set id: e80fc706-62c7-497b-af15-20246f17228f
Version: 1
Effective Time: 20150209
 
Pharmco Laboratories Inc.