Clearskin
FDA Label NDC 10096-0154

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 10096-0154). 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 - when using, warnings and precautions, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active/Medicinal Ingredient
Salicylic Acid 0.50%..............................

Otc - Purpose

                Purpose
...............Acne Treatment

Indications & Usage

Uses

  • for the treatment of acne
  • reduces the number of acne blemishes
  • helps clear up most acne blemishes

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 irritation persists, seek medical attention.
  • discontinue use if excessive skin irritation develops or increases. If irritationpersists, consult a health care practitioner.
  • using other topical acne products at the same time or immediately afterthis 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

Warnings And Precautions

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.

Dosage & Administration

Directions

  • cleanse skin thoroughly before applying product
  • apply a thin layer of product to affected areas one to three times daily or as directed by a health care practitioner
  • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two to three times 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 WATER/EAU, SD ALCOHOL 40-B, DIMETHICONE, C12-15 ALKYL BENZOATE, KAOLIN, PROPYLENE GLYCOL, CYCLOPENTASILOXANE, CETEARYL ALCOHOL, CETYL ALCOHOL, ETHYLHEXYL
METHOXYCINNAMATE, STEARYL ALCOHOL, THIODIPROPIONIC ACID, ZINC HEXAPEPTIDE-11, HEXAPEPTIDE-11, GLYCOLIC ACID, PALMITOYL OLIGOPEPTIDE, PALMITOYL TETRAPEPTIDE-7, RETINYL PALMITATE, TRITICUM VULGARE (WHEAT) GERM EXTRACT, CINNAMOMUM ZEYLANICUM BARK EXTRACT, SARCOSINE, TOCOPHEROL, CAPRYLOYL GLYCINE, PVM/MA DECADIENE CROSSPOLYMER, CYCLOHEXASILOXANE, STEARETH-21, CETEARETH-20, DIMETHICONE CROSSPOLYMER, PEG-40 STEARATE, CARBOMER, POLYSORBATE 20, HEXYLENE GLYCOL, ISODODECANE, POLYSORBATE 60, PEG-150 STEARATE, STEARETH-20, GLYCERIN, BUTYLENE GLYCOL, POLYSTYRENE/HYDROGENATED POLYISOPENTENE COPOLYMER, PARFUM/FRAGRANCE, SODIUM HYDROXIDE, DISODIUM EDTA, METHYLPARABEN, PROPYLPARABEN, PHENOXYETHANOL.

Otc - Questions

Questions?
Call 1-800-FOR-AVON

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