SLMD Spot Treatment

Manufacturer
Owen Biosciences, Inc.
Effective date
2025-01-13
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 20:42:55

Label at a glance#

ProductSLMD Spot Treatment
Active ingredientBENZOYL PEROXIDE
Label structure11 sections

Dosage and administration

Clean the skin thoroughly before applying 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 to three times daily if needed or as directed by a doctor.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzoyl Peroxide 10%

Use

INDICATIONS & USAGE SECTION

for the management of acne

Warnings For external use only 

WARNINGS SECTION

When using this product

skin irritation and 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 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 possibly swelling.  Irritation may be reduced by using this product less frequently or in a lower concentration

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

OTC - WHEN USING SECTION

  • Clean the skin thoroughly before applying 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 to three times daily if needed or as directed by a doctor.

OTC - PURPOSE SECTION

acne treatment      

DOSAGE & ADMINISTRATION SECTION

topical cleanser

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua)
Propanediol
Glycerin
Neopentyl Glycol Diethylhexanoate
Dimethicone
Cyclopentasiloxane
Cyclohexasiloxane
Titanium Dioxide
C12-15 Alkyl Benzoate
Stearic Acid
Behenoxy Dimethicone
Behenyl Alcohol
Glyceryl Stearate
PEG-100 Stearate
Myristoyl Tetrapeptide-13
Acetyl Carboxymethyl Cocoyl Glycine
Panthenol
Tocopheryl Acetate
Sodium Hyaluronate
Allatoin
Glyceryl Oleate
Behenic Acid
Steareth-21
Steareth-2
Silica
Carbomer
Acrylates/C10-30 Alkyl Acrylate Crosspolymer
Phenoxyethanol
Ethylhexylglycerin
Fragrance
Tromethamine
Alumina
Polyhydroxystearic Acid

Do not use if

OTC - DO NOT USE SECTION

  • have very senstive skin
  • are sensitive to benzoyl peroxide

Stop us and ask a doctor if

OTC - ASK DOCTOR SECTION

irritation becomes severe

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionAcne Spot Treatment Back.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59958-401-012021-07-15C16284748780-1ba0f9c33-328b-a910-e053-dadaa90a0b85SLMD Moisturizer with SPF
59958-401-012021-01-29C16284748780-1ba0f9c33-328b-a910-e053-dadaa90a0b85SLMD Moisturizer with SPF

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59958-401SLMD SPOT TREATMENT (BENZOYL PEROXIDE) GEL [OWEN BIOSCIENCES, INC.]5Legacy NDC20250114_8d83ebaa-a292-402b-b239-bd603c52f396.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59958-40159958-401-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 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
5a31c580-fe40-bad4-e063-6294a90a7ef88d83ebaa-a292-402b-b239-bd603c52f3962026-08-29WarningsExact identifier
spl set id: 8d83ebaa-a292-402b-b239-bd603c52f396

Reported adverse events (FAERS/openFDA)#

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