Slmd Spot Treatment
FDA Label NDC 59958-401

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Owen Biosciences, Inc. for the product Slmd Spot Treatment (NDC 59958-401). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, use, warningsfor external use only, keep out of reach of children., directions, inactive ingredients, do not use if, stop us and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Benzoyl Peroxide 10%

Use

for the management of acne

Warningsfor External Use Only

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.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • 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.

Inactive Ingredients

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

  • have very senstive skin
  • are sensitive to benzoyl peroxide

Stop Us And Ask A Doctor If

irritation becomes severe

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