SLMD AM Benzoyl Peroxide Acne Treatment

Manufacturer
Owen Biosciences, Inc.
Effective date
2023-01-16
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:40:25

Label at a glance#

ProductSLMD AM Benzoyl Peroxide Acne Treatment
Active ingredientBENZOYL PEROXIDE
Label structure11 sections

Dosage and administration

Clean the skin thoroughly before applying this product cover the entire affected area with a thin layer one to three times daily

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzoyl Peroxide 2.5%

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 this product
  • cover the entire affected area with a thin layer one to three times daily

OTC - PURPOSE SECTION

acne treatment      

DOSAGE & ADMINISTRATION SECTION

topical cleanser

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua)
Behenoxy Dimethicone
Cyclohexasiloxane
Cyclopentasiloxane
Dimethicone
Glyceryl Stearate SE
Acetyl Carboxymethyl Cocoyl-Glycine
Lysozyme
Phenoxyethanol
Tocopheryl Acetate
Decylene Glycol
Maltodextrin
Glyceryl Stearate
PEG-100 Stearate
Caprylyl Glycol
C13-14 Isoparaffin
Laureth-7
Polyacrylamide
Sodium Carboxymethyl Betaglucan
Cocoglycerides
Glycerin
Lecithin
Palmitoyl Myristyl Serinate
Syringa Vulgaris (Lilac) Extract
Butylene Glycol
Propanediol
Mirabilis Jalapa Extract
Aloe Barbadensis Leaf Juice
Capryloyl Glycine
Polyglyceryl-10 Laurate
Tromethamine
Beta-Glucan
Myristoyl Tetrapeptide-13
Acrylates/C10-30 Alkyl Acrylate Crosspolymer

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

Acne Lotion Back.jpg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Acne Lotion Back.jpg

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59958-402SLMD AM BENZOYL PEROXIDE ACNE TREATMENT (BENZOYL PEROXIDE) GEL [OWEN BIOSCIENCES, INC.]4Legacy NDC20230117_a6c1701d-b59a-41ae-b4f3-725cc59522fe.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59958-40259958-402-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 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
f267a49e-2622-0768-e053-2a95a90a8258a6c1701d-b59a-41ae-b4f3-725cc59522fe2023-01-16WarningsExact identifier
spl id: f267a49e-2622-0768-e053-2a95a90a8258
spl set id: a6c1701d-b59a-41ae-b4f3-725cc59522fe

Reported adverse events (FAERS/openFDA)#

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