Pca Skin Acne Cream
FDA Label NDC 68726-169

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cp Skin Health Group, Inc. for the product Pca Skin Acne (NDC 68726-169). 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, indications & usage, warnings, otc - keep out of reach of children, 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 INGREDIENT:                 Benzoyl Peroxide (5.0%)                      

Otc - Purpose

Purpose: Acne Treatment

Indications & Usage

USES:
  • Treats existing and helps prevent new acne blemishes/blackheads.

Warnings


WARNINGS:

  • When using this product, avoid unnecessary sun exposure and use a sunscreen.
  • For external use only
  • Using other topical acne drugs 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 drug should be used unless directed by a physician.
  • Do not use in or near the eyes.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center Immediately.

Dosage & Administration

DIRECTIONS: Cleanse skin thoroughly before applying.  Apply a small amount of cream to areas where pimples occur.  Do not rinse.   Start with one acne treatment every other day and gradually increase to once daily or as directed by a physician. If going outside, use a sunscreen. Allow Acne Cream to dry, then follow sunscreen label directions.  If irritation develops or sensitivity develops, discontinue use of both products and consult a physician.

Inactive Ingredient

Other Ingredients: Water/Aqua/Eau, Gluconolactone, Glycerin, Caprylic/Capric Triglyceride, Cetyl Alcohol, Vitis Vinifera (Grape) Seed Oil, Aminomethyl Propanol, Lactic Acid, Aloe Barbadensis Leaf Juice, Cyclopentasiloxane, Dimethicone, Glyceryl Stearate, PEG-100 Stearate, Melaleuca Arternifolia (Tea Tree) Leaf Oil, Tocopheryl Acetate, Ascorbic Acid, Retinyl Palmitate, Anthemis Nobilis Flower Extract, Citrus Grandis (Grapefruit) Peel Oil, Allantoin, Panthenol, Polyacrylate-13, Polyisobutene, Caprylyl Glycol, Ammonium Acryloyldimethyltaurate/VP Copolymer, Potassium Cetyl Phosphate, Ethylhexylglycerin, Hexylene Glycol, Polysorbate 20, Butylene Glycol, Phenoxyethanol.

* Please review the disclaimer below.