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  5. Label Information: Blemish

FDA Label for Blemish

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. OTC - KEEP OUT OF REACH OF CHILDREN
    4. INDICATIONS & USAGE
    5. WARNINGS
    6. DOSAGE & ADMINISTRATION
    7. INACTIVE INGREDIENT
    8. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Blemish Product Label

The following document was submitted to the FDA by the labeler of this product Kamins Dermatologics 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.

Otc - Active Ingredient



Active ingredients:Benzoyl Peroxide: 10%

Otc - Purpose



Purpose: Acne Treatment

Otc - Keep Out Of Reach Of Children



Keep out of children’s reach.

Indications & Usage



A unique oil-free, color-free benzoyl peroxide gel that helps to gently clear blemishes, blackheads and spots.  Also contains our moisturizing Bio-Maple compound, which helps prevent skin from becoming excessively dry.

Uses

■ Helps treat acne.

■ Dries up acne pimples.

■ Helps prevent new acne pimples.


Warnings



Warnings

For external use only.

Do not use on

  • broken skin.
    • large areas of the body.

      • When using this product,

      • Apply to affected areas only
      • avoid unnecessary sun exposure and use a sunscreen
      • avoid contact with eyes/eye area, lips, mouth and nostrils.  If contact occurs, rinse thoroughly with water.
      • This product may bleach hair or dyed fabrics.
      • Using other topical acne drugs at the same time or right after use of this product may increase dryness or irritation of the skin.  Only one drug should be used unless directed by a doctor.

        • Stop use and ask a doctor if too much skin irritation or sensitivity develops or increases.

        If swallowed, seek medical assistance or contact a Poison Control Center immediately.


Dosage & Administration



Directions

  • Clean the skin thoroughly befor applying.
  • Cover the entire affected area 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 2-3 times daily if needed or as directed by a doctor.
  • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
  • If going outside, use a sunscreen.  Allow medicated acne gel to dry, then follow directions on the sunscreen labeling.

Inactive Ingredient



INACTIVE INGREDIENTS: water, alcohol denat., acer saccharum (maple isolate), disodium PEG-12 dimethicone sulfosuccinate, carbomer, sodium hydroxide, phenoxyethanol, caprylyl glycol, sorbic acid


Package Label.Principal Display Panel



B. KAMINS

BLEMISH GEL 10%

30mL / 1.7 fl.oz

BLEMISH GEL front panel image - Blemish Gel

BLEMISH GEL front panel image - Blemish Gel


* Please review the disclaimer below.