Clearskin Blemish Clearing Spot Treatment: Package Insert and Label Information

CLEARSKIN BLEMISH CLEARING SPOT 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 2.0%…………………….Acne Treatment

Uses

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

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 medications 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. 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, irritation or peeling occurs, reduce application to once a day or every other day

Inactive ingredients

WATER/EAU
SD ALCOHOL 40-B
PROPYLENE GLYCOL
ETHOXYDIGLYCOL
TRIDECETH-9
HYDROXYETHYLCELLULOSE
TRITICUM VULGARE (WHEAT) GERM EXTRACT
PUNICA GRANATUM FRUIT JUICE
ALOE BARBADENSIS LEAF JUICE
CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT
HAMAMELIS VIRGINIANA (WITCH HAZEL) EXTRACT
XANTHAN GUM
DISODIUM EDTA
AMMONIUM HYDROXIDE PARFUM/FRAGRANCE

Questions? Call 1-800-FOR-AVON

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CLEARSKIN BLEMISH CLEARING SPOT TREATMENT salicylic acid gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:10096-0223
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Salicylic acid (Salicylic acid) Salicylic acid 0.3 mL in 15 mL
Inactive Ingredients
Ingredient Name Strength
WATER
PROPYLENE GLYCOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10096-0223-2 1 TUBE (TUBE) in 1 CARTON contains a TUBE (10096-0223-1)
1 NDC:10096-0223-1 15 mL in 1 TUBE This package is contained within the CARTON (10096-0223-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333 06/14/2010
Labeler — Avon Products, Inc. (001468693)
Establishment
Name Address ID/FEI Operations
Avon Products, Inc. 005149471 manufacture

Revised: 06/2010 Avon Products, Inc.

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