ACNE SPOT REPAIR

Manufacturer
menScience Androceuticals, LLC
Effective date
2017-04-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:16:45

Label at a glance#

ProductACNE SPOT REPAIR
Active ingredientBENZOYL PEROXIDE
Label structure6 sections

Indications and uses

for the treatment and prevention of acne

Dosage and administration

Clean the skin before applying  Cover only acne spot  with a thin layer 1 to 3 times daily Because too much drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 times daily if needed or as directed by a doctor If dryness or peeling occurs, reduce application to once a day or every other day. If going outside, allow product to dry, then use a sunscreen  Store at 20-25°C (6...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzoyl Peroxide 10%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Uses

INDICATIONS & USAGE SECTION

for the treatment and prevention of acne

Warnings

WARNINGS SECTION

For external use only.

Do not use:

OTC - DO NOT USE SECTION

If you have very sensitive skin or are sensitive to benzoyl peroxide

When using this product:

OTC - WHEN USING SECTION

  • Apply to affected areas only
  • Avoid unnecessary sun exposure and use a sunscreen 
  • Do not use in or near the eyes, lips or mouth 
  • This product may bleach hair or dyed fabrics
  • Using other topical acne medications at the same time or right after use of this product may increase dryness or irritation of the skin 

Discontinue use and ask a doctor

OTC - ASK DOCTOR SECTION

If skin irritation becomes severe or if you are using more than one acne medication 

Keep out of reach of children. 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a poison control center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Clean the skin before applying 
  • Cover only acne spot  with a thin layer 1 to 3 times daily
  • Because too much drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 times daily if needed or as directed by a doctor
  • If dryness or peeling occurs, reduce application to once a day or every other day.
  • If going outside, allow product to dry, then use a sunscreen 
  • Store at 20-25°C (68-77°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua purificata, c12-15 alkyl benzoate, urea, butylene glycol, cyclopentasiloxane, magnesium aluminum silicate, steareth-20, peg-100 stearate, zea mays, hydroxyethyl acrylate/sodium acryloyldimethyl, taurate copolymer, squalane, polysorbate 60, chamomilla recutita extract, camellia oleifera leaf extract, phospholipids, retinyl palmitate, tocopherol, ascorbyl palmitate, beta-carotene, ethylhexylglycerin, cetearyl alcohol, glycerin, caprylyl glycol, dimethicone, acrylates/c10-30 alkly acrylate crosspolymer, steareth-2, butylene glycol, propylene glycol, panthenol, disodium EDTA, allantoin, phytonadione.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130185219000345GTIN-13: 0185219000345
EAN-13: 0185219000345
GTIN-12: 185219000345
UPC-A: 185219000345
GTIN storage (14 digits): 00185219000345
Label2.jpg

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71397-82171397-821-75

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 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
071db3a6-4dff-0d92-e063-6394a90a24164dec259d-1ff5-44f2-e054-00144ff8d46c2023-10-07WarningsExact identifier
spl set id: 4dec259d-1ff5-44f2-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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