Healthy Skin Moisturizer
FDA Label NDC 52261-3801

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cosco International, Inc. for the product Healthy Skin Moisturizer (NDC 52261-3801). 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 drug facts, otc - purpose, warnings, otc - do not use, otc - ask doctor/pharmacist, indications & usage, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient               Purpose

Benzoyl Peroxide 2.5%.........Acne Treatment

Otc - Purpose

Use

  • For the treatment of acne.

Warnings

Warnings

For external use only

Otc - Do Not Use

Do not use

  • If you are sensitive to Benzoyl Peroxide or have very sensitive skin.  This product may cause irritation.
  • If you are pregnant or breast feeding.

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use

  • If you are using other topical ance drugs at the same time or right after use of this product.  This may increase dryness, redness, or irritation of the skin.  If this occurs, only one medication should be used unless a doctor directs otherwise.

Indications & Usage

When using this product

  • Avoid contact with eyes.  If contact occurs, flush thoroughly with water.  Keep away from lips and mouth.
  • Avoid unneccesary sun exposure and use a sunscreen.
  • Avoid product contact with hair and dyed fabrics, including carpets and clothing which may be bleached by this product.

Otc - Stop Use

Stop use and ask a doctor

  • If excessive irritation occurs.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

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

Dosage & Administration

Directions

  • Use every morning and evening.  Apply to entire face, avoiding the eye area.  Do not rinse.  If peeling occurs, reduce application use.  May also be used on chest and back.

Inactive Ingredient

Inactive Ingredients  .Alpha.Tocopherol, DL-, Actinidia Chinensis (Kiwi) Fruit Extract, Aminomethylproanol, Cannabis Sativa Seed Oil, Caprylyl Glycol, Cetyl Alcohol, Citrullus Lanatis (Watermelon) Fruit Extract, Ethylhexylglycerin, Glycerin, Glyceryl Monostearate, Isopropyl Palmitate, Lens Esculenta (Lentil) Fruit Extract, Medium-Chain Triglycerides, Persea Gratissima (Avocado) Oil, Phenoxyethanol, Pyrus Malus (Apple) Fruit Extract, Sodium Lactate, Sodium Pyrrolidone Carboxylate, Sorbic Acid, Stearic Acid, Water, Xanthan Gum

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