CT07 BENZOYL PEROXIDE TREATMENT- benzoyl peroxide gel

CT07 Benzoyl Peroxide Treatment by

Drug Labeling and Warnings

CT07 Benzoyl Peroxide Treatment by is a Otc medication manufactured, distributed, or labeled by Pharmco Laboratories, Inc., Pharmco Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS

Active Ingredient

2.5% Benzoyl Peroxide

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 & 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 sunscreen.
• Avoid contact with 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 lower concentration.
• If going outside, apply sunscreen after using this product.

• Stop use and ask a doctor if irritation becomes severe.

• 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.
• Clover the entire affected area with a thin layer one to three times per day.
• Because excessive drying 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 and peeling occurs, reduce application to once a day or every other day.
• If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use both products and ask doctor.

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.

PRINCIPAL DISPLAY PANEL - 60 g Tube Carton

clearup

Anti-acne
Clearing Gel

Micronized
Benzoyl Peroxide

2.5%

PREVENTS & TREATS BREAKOUTS

MADE IN THE USA
ADVANCED FORMULA
GEL TEXTURE

60g / 2.1 oz

INGREDIENTS AND APPEARANCE

CT07 BENZOYL PEROXIDE TREATMENT 
benzoyl peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58400-024
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	25 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58400-024-02	60 g in 1 TUBE; Type 0: Not a Combination Product	07/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M006	07/01/2024

Labeler - Pharmco Laboratories, Inc. (096270814)

Establishment
Name	Address	ID/FEI	Business Operations
Pharmco Laboratories Inc.		119071691	ANALYSIS(58400-024) , MANUFACTURE(58400-024) , PACK(58400-024) , LABEL(58400-024)

Establishment
Name	Address	ID/FEI	Business Operations
Pharmco Laboratories Inc.		119071697	MANUFACTURE(58400-024) , PACK(58400-024) , LABEL(58400-024)