Blemish
FDA Label NDC 63550-194

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kamins Dermatologics Inc. for the product Blemish (NDC 63550-194). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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)

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