BENZOYL PEROXIDE CLEANSER- benzoyl peroxide gel 
Pharmco Laboratories Inc.

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Benzoyl Peroxide Cleanser 3.5%

Drug Facts

Active Ingredient

Benzoyl Peroxide 3.5%

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

  • Keep away from excessive heat or heat sources

Directions

Other Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, C12-14 Alkyl Olefin Sulfonate, Disodium Cocoamphodiacetate, Edetate Disodium, Ethylhexylglycerin, FD&C Yellow # 5, Glycerine, Panthenol, Perlite, Phenoxyethanol, Propylene Glycol, Sodium Hyaluronate, 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

PRINCIPAL DISPLAY PANEL - 170 g Bottle Label

PHARMCO
SKINCARE LABS

Benzoyl Peroxide
Cleansing Gel 3.5%

Net wt. 6 oz. (170 g)

PRINCIPAL DISPLAY PANEL - 170 g Bottle Label
BENZOYL PEROXIDE CLEANSER 
benzoyl peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58400-009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide35 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
SODIUM C12-14 OLEFIN SULFONATE (UNII: 7I962MCQ71)  
Disodium Cocoamphodiacetate (UNII: 18L9G3U51M)  
Glycerin (UNII: PDC6A3C0OX)  
Propylene Glycol (UNII: 6DC9Q167V3)  
PERLITE (UNII: 0SG101ZGK9)  
Allantoin (UNII: 344S277G0Z)  
Panthenol (UNII: WV9CM0O67Z)  
Hyaluronate Sodium (UNII: YSE9PPT4TH)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
Edetate Disodium (UNII: 7FLD91C86K)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Ethylhexylglycerin (UNII: 147D247K3P)  
Sodium Hydroxide (UNII: 55X04QC32I)  
FD&C Yellow NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58400-009-01170 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product12/01/2016
2NDC:58400-009-023900 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph drugM00612/01/2016
Labeler - Pharmco Laboratories Inc. (096270814)
Establishment
NameAddressID/FEIBusiness Operations
Pharmco Laboratories Inc.096270814MANUFACTURE(58400-009) , LABEL(58400-009) , PACK(58400-009) , ANALYSIS(58400-009)

Revised: 1/2024
Document Id: 1440605b-a17e-4497-99ad-7ef4a90285b6
Set id: 1a28b82b-e7da-428f-a9bf-68ef8d0db070
Version: 4
Effective Time: 20240110
 
Pharmco Laboratories Inc.