MICRONIZED BENZOYL PEROXIDE TREATMENT- benzoyl peroxide gel 
Pharmco Laboratories Inc.

----------

Micronized Benzoyl Peroxide Treatment 10%

Drug Facts

Active Ingredient

Benzoyl Peroxide 10%

Purpose

Acne Treatment

Uses

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

Directions

Other Ingredients

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

Other Information

Store at 15 - 25°C (59 - 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 CPL78-2

PRINCIPAL DISPLAY PANEL - 59 g Tube Label

PHARMCO
SKINCARE LABS

Micronized
Benzoyl Peroxide
Treatment Gel
10%

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:58400-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide100 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:58400-003-0159 g in 1 TUBE; Type 0: Not a Combination Product06/01/2012
2NDC:58400-003-023900 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00606/01/2012
Labeler - Pharmco Laboratories Inc. (096270814)
Establishment
NameAddressID/FEIBusiness Operations
Pharmco Laboratories Inc.096270814MANUFACTURE(58400-003) , LABEL(58400-003) , PACK(58400-003) , ANALYSIS(58400-003)

Revised: 1/2024
Document Id: 827b1a9f-70ed-4b5a-80c6-ec249ec22969
Set id: 08f6876e-0c1e-4954-8c49-0b309ac3c949
Version: 4
Effective Time: 20240110
 
Pharmco Laboratories Inc.