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

Manufacturer
Clove Hill LLC
Effective date
2023-01-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:40:44

Label at a glance#

ProductACNE 10%
Active ingredientBENZOYL PEROXIDE
Label structure9 sections

Indications and uses

For the treatment of acne

Dosage and administration

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 S...

Storage and handling

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

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

BENZOYL PEROXIDE 10%

PURPOSE

OTC - PURPOSE SECTION

Acne medication

USES

INDICATIONS & USAGE SECTION

  • For the treatment of acne

WARNINGS

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

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

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

WATER, PROPANEDIOL, GLYCERIN, CARBOMER, SODIUM HYDROXIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01B LBL_ACNE GEL01B LBL_ACNE GEL

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82746-32082746-320-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f21b560f-f5c4-2bfb-e053-2a95a90aa353f216b61d-ef22-61c3-e053-2a95a90ac5f92023-01-12WarningsExact identifier
spl id: f21b560f-f5c4-2bfb-e053-2a95a90aa353
spl set id: f216b61d-ef22-61c3-e053-2a95a90ac5f9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.