1. Home
  2. Labeler Index
  3. Owen Biosciences, Inc.
  4. 59958-401
  5. Label Information: Slmd Spot Treatment

FDA Label for Slmd Spot Treatment

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. USE
    3. WARNINGSFOR EXTERNAL USE ONLY
    4. KEEP OUT OF REACH OF CHILDREN.
    5. DIRECTIONS
    6. INACTIVE INGREDIENTS
    7. DO NOT USE IF
    8. STOP US AND ASK A DOCTOR IF

Slmd Spot Treatment Product Label

The following document was submitted to the FDA by the labeler of this product Owen Biosciences, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


* Please review the disclaimer below.