Clear Acne Kit
FDA Label NDC 50718-0034

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kamedis for the product Clear Acne Kit (NDC 50718-0034). 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 step 1 - acne face cleanserdrug facts, active ingredient, purpose, use, warnings, when using this product, stop use and ask a doctor, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Step 1 - Acne Face Cleanserdrug Facts

Active Ingredient

Salicylic acid 1.0%

Salicylic acid 2.0%

Salicylic acid 2.0%

Purpose

Acne Treatment

Acne Treatment

Acne Treatment

Use

  • For the treatment of acne
    • For the treatment of acne
      • For the treatment of acne

Warnings

For external use only

For external use only

For external use only

When Using This Product

  • Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.
  • Using other topical acne medication at the same time or immediately following the use of this product may increase dryness or irritation of the skin. If this occurs, only one medication at a time should be used, unless otherwise directed by a doctor.
    • Avoid unnecessary sun exposure and use sunscreen.
    • Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.
    • Using other topical acne medication at the same time or immediately following the use of this product may increase dryness or irritation of the skin. If this occurs, only one medication at a time should be used, unless otherwise directed by a doctor.
      • Avoid unnecessary sun exposure and use sunscreen.
      • Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.
      • Using other topical acne medication at the same time or immediately following the use of this product may increase dryness or irritation of the skin. If this occurs, only one medication at a time should be used, unless otherwise directed by a doctor.

Stop Use And Ask A Doctor

  • If irritation persists
    • If irritation persists
      • If irritation persists

Keep Out Of Reach Of Children

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

Directions

  • Wet face. Apply to hands, add water and work into lather. Gently massage all over face avoiding eye area. Rinse thoroughly and pat dry. Good for daily use.
  • 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 or three 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
  • For children under 10 years of age, consult your physician.
    • Cleanse the skin thoroughly before applying medication.
    • 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 or three 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.
    • For children under 10 years of age, consult your physician.
      • Cleanse the skin thoroughly before applying medication.
      • 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 or three 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.
      • For children under 10 years of age, consult your physician.

Inactive Ingredients

Benzyl Alcohol, Chlorphenesin, Cocamide MEA, Cocamidopropyl Betaine, Common Purslane (Portulaca Oleracea) Extract, Fragrance, Glycerin, Glyceryl Stearate SE, Hexylene Glycol, Hydrolyzed Jojoba Ester, Lauroyl Lysine, Methyl Glucose Caprate/ Caprylate/ Oleate, Myristic Acid, Propanediol, Salt (Sodium Chloride), Soapberry (Sapindus Mukurossi) Fruit Extract, Sodium Cocoyl Apple Amino Acids, Sodium Hydroxide, Sodium Lauroyl Methyl Isethionate, Sodium Methyl Cocoyl Taurate, Squalane, Stearic Acid, Tetrasodium EDTA, Trisodium Ethylenediamine Dissuccinate, Vitamin E (Tocopheryl Acetate), Water, Xanthan Gum.

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Alcohol, Amur Cork Tree (Phellodendron Amurense) Bark Extract, Baikal Skullcap (Scutellaria Baicalensis) Root Extract, Benzyl Alcohol, Capryloyl Glycine, Chinese Rhubarb (Rheum Palmatum ) Root Extract, Chlorphenesin, Chrysanthemum (Chrysanthemum Indicum) Flower Extract, Cinnamon (Cinnamomum Zeylanicum) Bark Extract, Common Purslane (Portulaca Oleracea) Extract, Fragrance, Glycerin, Great Burnet (Sanguisorba Officinalis) Root Extract, Hexylene Glycol, Norway Spruce (Picea Abis) Extract, Propanediol, Sarcosine, SD Alcohol 40-C, Sodium Phytate, Tromethamine, Water, Xanthan Gum

Alcohol, Arachidyl Alcohol, Arachidyl Glucoside, Ascorbyl Tetraisopalmitate, Baikal Skullcap (Scutellaria Baicalensis) Root Extract, Behenyl Alcohol, Benzyl Alcohol, Capryloyl Glycine, Carbomer, Cetyl Alcohol, Chlorphenesin, Chinese Rhubarb (Rheum Palmatum) Root Extract, Chrysanthemum (Chrysanthemum Indicum) Flower Extract, Cinnamon (Cinnamomum Zeylanicum) Bark Extract, Common Purslane (Portulaca Oleracea) Extract, Dicaprylyl Carbonate, Fragrance, Glucose, Glycerin, Hexylene Glycol, Norway Spruce (Picea Abis) Extract, Phenethyl Alcohol, Plankton Extract, Propanediol, Sarcosine, SD Alcohol 40-C, Shea Butter (Butyrospermum Parkii), Sodium Hydroxide, Sodium Phytate, Squalane, Stearyl Alcohol, Water, Xanthan Gum.

Questions Or Comments?

1-855-626-6606

1-855-626-6606

1-855-626-6606

Step 2 - Acne Spot Treatmentdrug Facts

Step 3 - Acne Face Moisturizerdrug Facts

Carton Label

Image Description (Acne Cleanser Carton)

Image Description (Acne Cleanser Carton)

Image Description (Acne Spot Treatment Carton)

Image Description (Acne Spot Treatment Carton)

Image Description (Acne Moisturizer Carton)

Image Description (Acne Moisturizer Carton)

Image Description (Acne Kit Carton)

Image Description (Acne Kit Carton)

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