BENZOYL PEROXIDE CLEANSER- benzoyl peroxide gel

Benzoyl Peroxide Cleanser by

Drug Labeling and Warnings

Benzoyl Peroxide Cleanser by is a Otc medication manufactured, distributed, or labeled by Pharmco Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Benzoyl Peroxide 3.5%

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 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

• Use once or twice daily. Morning and/or night.
• Apply to damp skin and Wash-In for up to 1 minute.
• Do not get in the eyes.
• For best results, use fingertips and apply to affected areas with gentle pressure in a circular motion.
• Rinse off with warm water and pat dry with soft towel.
• If going outside, apply broad spectrum sunscreen SPF 15 or higher.

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.

SPL UNCLASSIFIED SECTION

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)

INGREDIENTS AND APPEARANCE

BENZOYL PEROXIDE CLEANSER 
benzoyl peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58400-009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM)	Benzoyl Peroxide	35 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58400-009-01	170 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	12/01/2016
2	NDC: 58400-009-02	3900 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	12/01/2016

Labeler - Pharmco Laboratories Inc. (096270814)

Establishment
Name	Address	ID/FEI	Business Operations
Pharmco Laboratories Inc.		096270814	MANUFACTURE(58400-009) , LABEL(58400-009) , PACK(58400-009) , ANALYSIS(58400-009)