CLEARSKIN PROFESSIONAL INVISIBLE BLEMISH TREATMENT: Package Insert and Label Information

CLEARSKIN PROFESSIONAL INVISIBLE BLEMISH TREATMENT- salicylic acid gel
Avon Products, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredient Purpose

Salicylic Acid 2.00%………………………………Acne Treatment

Uses

  • for the treatment of acne
  • reduces the number of acne blemishes
  • clears up most acne blemishes

Warnings For external use only

When using this product

  • avoid contact with eyes. If product contacts eyes, rinse thoroughly with water.
  • using other topical acne products at the same time or immediately after this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor

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

Flammable

Flammable. Keep away from heat or flame.

Directions

  • cleanse skin thoroughly before applying medication
  • cover the entire affected area with 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 to three times daily if needed or as directed by a doctor
  • if bothersome dryness or peeling occurs, reduce application to once aday or every other day

Inactive ingredients Water/Eau, SD Alcohol 40-B, Propylene Glycol,
Trideceth-9, Ethoxydiglycol, Hydroxyethylcellulose, Hamamelis Virginiana
(Witch Hazel) Extract, Triticum Vulgare (Wheat) Germ Extract, Aloe Barbadensis
Leaf Juice, Punica Granatum Fruit Juice, Silybum Marianum Extract,
Chamomilla Recutita (Matricaria) Flower Extract, Thiodipropionic Acid,
Saccharomyces/Zinc Ferment, Tocopherol, Styrene/VP Copolymer,
Xanthan Gum, Parfum/Fragrance, Isododecane, Polystyrene/Hydrogenated
Polyisopentene Copolymer, Sodium Laureth-40 Sulfate, Retinyl Palmitate,
Glycolic Acid, Ammonium Hydroxide, Disodium EDTA.

Questions? Call 1-800-FOR-AVON

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CLEARSKIN PROFESSIONAL INVISIBLE BLEMISH TREATMENT
salicylic acid gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:10096-0180
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Salicylic Acid (SALICYLIC ACID) Salicylic Acid 0.30 mL in 15 mL
Inactive Ingredients
Ingredient Name Strength
WATER
PROPYLENE GLYCOL
XANTHAN GUM
ISODODECANE
GLYCOLIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10096-0180-2 1 TUBE (TUBE) in 1 CARTON contains a TUBE (10096-0180-1)
1 NDC:10096-0180-1 15 mL in 1 TUBE This package is contained within the CARTON (10096-0180-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333 12/10/2009
Labeler — Avon Products, Inc. (001468693)
Establishment
Name Address ID/FEI Operations
Avon Products, Inc. 005149471 manufacture

Revised: 12/2009 Avon Products, Inc.

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