Clove Hill (as PLD) - Acne Gel 10% (82746-320)

ACNE by

Drug Labeling and Warnings

ACNE by is a Otc medication manufactured, distributed, or labeled by Clove Hill LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACNE 10%- benzoyl peroxide gel 
Clove Hill LLC

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.

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Clove Hill (as PLD) - Acne Gel 10% (82746-320)

ACTIVE INGREDIENT

BENZOYL PEROXIDE 10%

PURPOSE

Acne medication

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 medicationat 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 possible swelling. Irritation may be reduced by using this product less frequently or in a lower concentration.

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

• CLEAN THE SKIN THOROUGHLY BEFORE APPLYING THE 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
• IF GOING OUTSIDE, APPLY SUNCREEN AFTER USING THIS PRODUCT. IF IRRITATION OR SENSITIVITY DEVELOPS, STOP USE OF BOTH PRODUCTS AND ASK A DOCTOR.

OTHER INFORMATION

STORE AT ROOM TEMPERATURE. KEEP AWAY FROM HEAT AND DIRECT SUNLIGHT.

INACTIVE INGREDIENTS

WATER, PROPANEDIOL, GLYCERIN, CARBOMER, SODIUM HYDROXIDE

ACNE  10%
benzoyl peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82746-320
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM HYDROXIDE (UNII: 55X04QC32I)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
PROPANEDIOL (UNII: 5965N8W85T)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82746-320-30	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/12/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M006	01/12/2023

Labeler - Clove Hill LLC (071183319)

Revised: 1/2023

Document Id: f21b560f-f5c4-2bfb-e053-2a95a90aa353

34390-5

Set id: f216b61d-ef22-61c3-e053-2a95a90ac5f9

Version: 3

Effective Time: 20230112