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← See all Micronized Benzoyl Peroxide Treatment brands

Micronized Benzoyl Peroxide Treatment

Dosage form: gel
Ingredients: Benzoyl Peroxide 25mg in 1g
Labeler: Pharmco Laboratories Inc.
NDC Code: 58400-001

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 2.5%

Drug Facts

Active Ingredient

Benzoyl Peroxide 2.5%

Purpose

Acne Treatment

Uses
  • For the treatment of acne

Warnings
  • For external use only

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 erduced by using the product less frequently or in a lower concentartion.
  • 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
  • Clean the skin thoroughly before applying this product
  • Cover the entire affected area with a thin layer one to three times daily
  • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
  • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
  • If going outside, apply broad spectrum sunscreen SPF 15 or higher.

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 CT07-2

PRINCIPAL DISPLAY PANEL - 59 g Tube Label

PHARMCO
SKINCARE LABS

Micronized
Benzoyl Peroxide
Treatment Gel
2.5%

Net wt. 2 oz. (59 g)

MICRONIZED BENZOYL PEROXIDE TREATMENT 
benzoyl peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58400-001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzoyl Peroxide (Benzoyl Peroxide) Benzoyl Peroxide25 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Water 
Glycerin 
Propylene Glycol 
Edetate Disodium 
Sodium Hydroxide 
Saccharide Isomerate 
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) 
Packaging
#Item CodePackage Description
1NDC:58400-001-0159 g in 1 TUBE
2NDC:58400-001-023900 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D06/01/2012
Labeler - Pharmco Laboratories Inc. (096270814)
Establishment
NameAddressID/FEIOperations
Pharmco Laboratories Inc.096270814MANUFACTURE(58400-001), LABEL(58400-001), PACK(58400-001), ANALYSIS(58400-001)

 
Pharmco Laboratories Inc.

← See all Micronized Benzoyl Peroxide Treatment brands

Medically reviewed on Jul 6, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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