Clearskin
FDA Label NDC 10096-0186

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by New Avon Llc for the product Clearskin (NDC 10096-0186). 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 indications & usage, warnings, otc - when using, user safety warnings, otc - keep out of reach of children, storage and handling, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Indications & Usage

Uses

  • for the treatment of acne
  • helps clear up acne blemishes
  • helps prevent new acne blemishes from forming

Warnings

Warnings
For external use only

Otc - When Using

When using this product

  • avoid contact with eyes. If product contacts eyes, rinse thoroughly with water.
  • if excessive skin irritation develops or increases, discontinue use. If irritation persists, consult a health care practitioner.
  • when using other topical acne products at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one product should be used unless directed by a health care practitioner.

User Safety Warnings


Sunburn Alert: Use only as directed. This product contains an alpha hydroxy acid that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Please limit sun exposure and apply a sunburn protectant while using this product and for a week afterwards.

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.

Storage And Handling

Flammable. Keep away from heat or flame.

Dosage & Administration

Directions

  • cleanse skin thoroughly with non-medicated cleanser before applying medication
  • apply to blemish-prone areas one to three times daily or as directed by a health care practitioner
  • do not rinse
  • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two to three time daily if needed or as directed by a health care practitioner
  • if bothersome dryness or peeling occurs, reduce application to once a day or every other day

Inactive Ingredient

Inactive/Non-medicinal ingredients/Ingrédients inactifs/non médicinaux
Water/Eau, SD Alcohol 40-B, Butylene Glycol, Glycerin, Glycolic Acid, Thiodipropionic Acid, Trioxaundecanedioic Acid, Triticum Vulgare (Wheat) Germ Extract, Perilla Ocymoides Leaf Extract, Bambusa Vulgaris Extract, Propylene Glycol, Ammonium Hydroxide, Disodium EDTA, Parfum/Fragrance


Otc - Questions

Questions? Call 1-800-FOR-AVON or 1-800-265-AVON in Canada


Otc - Active Ingredient

Active/Medicinal Ingredient.....Salicylic Acid 1.0%                    Purpose...... Acne Treatment

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