Benzoyl Peroxide by Prasco Laboratories / Group Parima BENZOYL PEROXIDE liquid

Benzoyl Peroxide by

Drug Labeling and Warnings

Benzoyl Peroxide by is a Otc medication manufactured, distributed, or labeled by Prasco Laboratories, Group Parima. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

     

Principal Display Panel

NDC: 66993-946-12

Benzoyl Peroxide

9%

Cleanser

FOR TOPICAL USE

PRASCO

NET WEIGHT 12 oz

(340.2 g)  

  

INGREDIENTS AND APPEARANCE

BENZOYL PEROXIDE 
benzoyl peroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66993-945
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	60 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66993-945-12	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/28/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	02/28/2019

BENZOYL PEROXIDE 
benzoyl peroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66993-946
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	90 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66993-946-12	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/28/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	02/28/2019

Labeler - Prasco Laboratories (065969375)

Registrant - Group Parima (252243785)