BENZOYL PEROXIDE- benzoyl peroxide liquid 
Prasco Laboratories

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.

----------

BENZOYL PEROXIDE-benzoyl peroxide liquid

Active ingredient(s)

 Benzoyl Peroxide USP

Purpose

 Acne medication

Use(s)

  • For the treatment of acne

Warnings

For external use only.

  • Avoid contact with eyes, eyelids, lips and mucous membranes.

Do not use if you

  • have very sensitive skin
  • are sensitive to benzoyl peroxide

When using this product

  • Avoid unnecessary sun exposure and use a sunscreen.
  • Avoid contact with eyes, lips, and mouth.
  • Avoid contact with hair or dyed fabrics, which may be bleached by this product.
  • Skin irritation may occur, characterized by redness, burning, itching, peeling, or possible swelling.
  • Irritation may be reduced by using the product less frequently or in a lower concentration.
  • 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.

Stop use and ask a doctor if irritation becomes severe.

Keep out of reach of children

 If swallowed, get medical help or contact a Poison Control Center right away.

Directions

 SHAKE WELL.

  • Clean the skin thoroughly before applying this product.
  • Sensitivity Test for a New User. 
    Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below.
  • One to three times daily, wet skin and cover the entire affected area with a thin layer, liberally applying to areas to be cleansed. Massage gently into skin for 10-20 seconds working into a full lather, rinse thoroughly and pat dry.
  • 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 going outside, apply sunscreen after using this product.
  • Follow directions in the sunscreen labeling.
  • If irritation or sensitivity develops stop use of both products and ask a doctor.

Other information

 Store at controlled room temperature, 15º-30ºC (59º-86ºF)

Inactive ingredients

 Carbomer interpolymer type A NF, cetyl alcohol NF, disodium oleamido MEA-sulfosuccinate, edetate disodium USP, glycerin USP, glyceryl stearate/PEG-100 stearate, laureth-12, magnesium aluminum silicate NF, propylene glycol USP, purified water USP, sodium coco-sulfate, sodium lauroamphoacetate, and xanthan gum NF.

Questions?

 call 1-866-525-0688.

Principal Display Panel

NDC 66993-945-12

Benzoyl Peroxide

6%

Cleanser

FOR TOPICAL USE

PRASCO

NET WEIGHT 12 oz

(340.2 g)

    Benzoyl Peroxide 

Principal Display Panel

NDC 66993-946-12

Benzoyl Peroxide

9%

Cleanser

FOR TOPICAL USE

PRASCO

NET WEIGHT 12 oz

(340.2 g)  

Benzoyl Peroxide  

BENZOYL PEROXIDE 
benzoyl peroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66993-945
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE60 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CETYL ALCOHOL (UNII: 936JST6JCN)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
LAURETH-12 (UNII: OAH19558U1)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM COCO-SULFATE (UNII: 3599J29ANH)  
SODIUM LAUROAMPHOACETATE (UNII: SLK428451L)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
DISODIUM OLEAMIDO MEA-SULFOSUCCINATE (UNII: 5M1101WGSY)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66993-945-12237 mL in 1 BOTTLE; Type 0: Not a Combination Product02/28/201911/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D02/28/201911/30/2020
BENZOYL PEROXIDE 
benzoyl peroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66993-946
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE90 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CETYL ALCOHOL (UNII: 936JST6JCN)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
LAURETH-12 (UNII: OAH19558U1)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM COCO-SULFATE (UNII: 3599J29ANH)  
SODIUM LAUROAMPHOACETATE (UNII: SLK428451L)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
DISODIUM OLEAMIDO MEA-SULFOSUCCINATE (UNII: 5M1101WGSY)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66993-946-12237 mL in 1 BOTTLE; Type 0: Not a Combination Product02/28/201911/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D02/28/201911/30/2020
Labeler - Prasco Laboratories (065969375)
Registrant - Group Parima (252243785)

Revised: 4/2020
 
Prasco Laboratories