MICRONIZED BPO WASH- 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 BPO Wash 5%

Drug Facts

Active Ingredient

Benzoyl Peroxide 5%


Acne Treatment


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


Apply a quarter-sized amount to damp skin with gentle pressure and work into lather. Rinse with lukewarm water and pat dry with soft towel. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two to three times daily or as directed by a physician or skincare professional. If bothersome dryness or peeling occurs, reduce frequency of applications. If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use and consult a physician or skin care professional.

Other Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, C12-14 Alkyl Olefin Sulfonate, Disodium Cocoamphodiacetate, Edetate Disodium, Ethylhexylglycerin, Glycerin, Panthenol, Phenoxyethanol, Polyethylene, Propylene Glycol, Sodium Hyaluronate, Sodium Hydroxide.

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 CPL02



BPO 5%

Net wt. 3.9 kg

Principal Display Panel - 3.9 kg Bottle Label
benzoyl peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58400-004
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)  
Disodium Cocoamphodiacetate (UNII: 18L9G3U51M)  
Allantoin (UNII: 344S277G0Z)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Ethylhexylglycerin (UNII: 147D247K3P)  
Panthenol (UNII: WV9CM0O67Z)  
Hyaluronate Sodium (UNII: YSE9PPT4TH)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Edetate Disodium (UNII: 7FLD91C86K)  
Sodium Hydroxide (UNII: 55X04QC32I)  
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58400-004-01240 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
2NDC:58400-004-023900 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)
NameAddressID/FEIBusiness Operations
Pharmco Laboratories Inc.096270814MANUFACTURE(58400-004) , LABEL(58400-004) , PACK(58400-004) , ANALYSIS(58400-004)

Revised: 2/2015
Document Id: d5d58791-3291-47ef-8761-e6e58884ffc2
Set id: fe1f2ccf-0181-4615-8f65-ae0541502ff3
Version: 1
Effective Time: 20150209
Pharmco Laboratories Inc.