FDA.reportPublic FDA data

Acne Spot Treatment

Manufacturer
MONAT GLOBAL CORP | Dermacare MFG
Effective date
2024-12-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 20:42:13

Label at a glance#

ProductAcne Spot Treatment
Active ingredientBENZOYL PEROXIDE
Label structure9 sections

Dosage and administration

Directions Clean 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 if going outside...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Benzoyl Peroxide 5.00%

OTC - PURPOSE SECTION

Purpose

Acne Treatment

INDICATIONS & USAGE SECTION

Uses

  • For the treatment of acne

WARNINGS SECTION

For external use only

Do not use if

OTC - DO NOT USE SECTION

Do not use if you

  • have very sensitive skin
  • are sensitive to benzoyl peroxide

OTC - WHEN USING SECTION

When using this product

  • skin irritation and dryness are more likely to occur if you use another topicalk acne medication at the same time. If irritation occurs, only use one topical acne treatment 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 a lower concentration.

Stop use and consult

OTC - STOP USE SECTION

Stop use and consult with a doctor if

  • irritation becomes severe.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact a poison control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions

  • Clean 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
  • if going outside. apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and sak a doctor.

Sensitivity Test for a new User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Water, Isostearyl Alcohol, Glycerin, Pentylene Glycol, Silica, Hamamelis Virginiana (Witch Hazel) Water, Epilobium Angustifolium Flower/Leaf/Stem Extract, Phragmites Communis Extract, Poria Cocos Extract, Niacinamide, Tocopheryl Acetate, Carbomer, Potassium Hydroxide, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA.

Questions or Comments

OTC - QUESTIONS SECTION

Questions or comments?

Toll-free number 1-800-878-1978

PRIMARY PACKAGE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TubeTube

OUTER PACKAGE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer packageOuter package

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78518-013ACNE SPOT TREATMENT (BENZOYL PEROXIDE) CREAM [MONAT GLOBAL CORP]2Unmatched20250119_f8700864-81e9-62eb-e053-6394a90a4aeb.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78518-01378518-013-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
NIACINAMIDE25X51I8RD4IACT
BENZOYL PEROXIDEW9WZN9A0GMACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
PENTYLENE GLYCOL50C1307PZGIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36IACT
DISODIUM EDTA-COPPER6V475AX06UIACT
ISOSTEARYL ALCOHOLQ613OCQ44YIACT
EPILOBIUM ANGUSTIFOLIUM LEAF7NV86426N2IACT
HAMAMELIS VIRGINIANA LEAF WATER8FP93ED6H2IACT
FU LINGXH37TWY5O4IACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT

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
46e0757f-c2e4-1f4f-e063-6294a90a024bf8700864-81e9-62eb-e053-6394a90a4aeb2025-12-26WarningsExact identifier
spl set id: f8700864-81e9-62eb-e053-6394a90a4aeb

Reported adverse events (FAERS/openFDA)#

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