MICRONIZED BENZOYL PEROXIDE TREATMENT- benzoyl peroxide gel

Micronized Benzoyl Peroxide Treatment by

Drug Labeling and Warnings

Micronized Benzoyl Peroxide Treatment 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 5%

Purpose

Acne Treatment

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

• 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.
• Other sun protection measures include limiting sun exposure and wearing protective clothing.

Other Ingredients

Carbomer, Edetate Disodium, Glycerine, Propylene Glycol, Saccharide Isomerate, Sodium Hydroxide, Water.

Other Information

Store at 20 - 25°C (68 - 77°F) Protect from heat. Keep container tightly closed.

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Manufactured by:
Pharmco Laboratories Inc. Titusville, FL 32780
www.pharmcolabs.com 1.800.635.0712 Reorder CPL79-2

PRINCIPAL DISPLAY PANEL - 59 g Tube Label

PHARMCO
SKINCARE LABS

Micronized
Benzoyl
Peroxide
Treatment
5%

Net wt. 2 oz. (59 g)

INGREDIENTS AND APPEARANCE

MICRONIZED BENZOYL PEROXIDE TREATMENT 
benzoyl peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58400-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM)	Benzoyl Peroxide	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
Propylene Glycol (UNII: 6DC9Q167V3)
Edetate Disodium (UNII: 7FLD91C86K)
Sodium Hydroxide (UNII: 55X04QC32I)
Saccharide Isomerate (UNII: W8K377W98I)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58400-002-01	59 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 58400-002-02	3900 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	06/01/2012

Labeler - Pharmco Laboratories Inc. (096270814)

Establishment
Name	Address	ID/FEI	Business Operations
Pharmco Laboratories Inc.		096270814	MANUFACTURE(58400-002) , LABEL(58400-002) , PACK(58400-002) , ANALYSIS(58400-002)