Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 9264b925-95aa-42dd-b370-ec9300bf7918
Route
TRANSDERMAL
Published
Effective Date 2021-05-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (0.5 1)
Inactive Ingredients
Carboxymethylcellulose Sodium Ethylene-vinyl Acetate Copolymer (9% Vinylacetate) Polyisobutylene (1000 Mw) Xanthan Gum Aloe Vera Leaf Tea Tree Oil Propylene Glycol Retinol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2021-05-27

Description

Salicylic Acid 0.5%

Purpose

Acne Treatment


Medication Information

Purpose

Acne Treatment

Description

Salicylic Acid 0.5%

Uses

For the treatment of acne

Warnings

For external use only.

Directions

Sensitiviy test for new user

  • Prior to first use, conduct a 24-hour patch test on a small area of your arm on clean, dry skin to determine skin reactivity.
  • Proceed with normal usage only if irritation does not occur, as directed below.
  • Cleanse face with soap and warm water to remove all traces of make-up, oil and dirt.
  • Select a dot-shaped patch that is larger than the acne blemish and adhere the patch over the area to be treated. 
  • After 8 hoiurs remove by gently peeling back and discarding.
  • Cleanse the treated area and apply another patch if desired.
Do Not Use
  • On irritated or sunburnt skin.
Label Copy

Questions?

Call 1-800-548-4097

Active Ingredient

Salicylic Acid 0.5%

Other Information
  • Store in a cool dry place, use immediately after removing from the sheet.
Inactive Ingredients

Cellulose Gum, Ethylene/VA Copolymer, Polyisobutene, Xanthan Gum, Aloe Barbadensis Leaf Extract, Melaleuca Alternifolia (Tea Tree) Oil, Propylene Glycol, Retinol.

When Using This Product
  • Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.
  • Avoid contact with eyes.
Stop Use and Ask A Doctor If
  • irritation or redness develops and persists.
Keep Out of Reach of Children.
  • If ingested get medical help or contact a Poison Control Center right away.

Structured Label Content

Uses

For the treatment of acne

Purpose

Acne Treatment

Warnings

For external use only.

Directions

Sensitiviy test for new user

  • Prior to first use, conduct a 24-hour patch test on a small area of your arm on clean, dry skin to determine skin reactivity.
  • Proceed with normal usage only if irritation does not occur, as directed below.
  • Cleanse face with soap and warm water to remove all traces of make-up, oil and dirt.
  • Select a dot-shaped patch that is larger than the acne blemish and adhere the patch over the area to be treated. 
  • After 8 hoiurs remove by gently peeling back and discarding.
  • Cleanse the treated area and apply another patch if desired.
Do Not Use (Do not use)
  • On irritated or sunburnt skin.
Label Copy (Label copy)

Questions?

Call 1-800-548-4097

Active Ingredient

Salicylic Acid 0.5%

Other Information (Other information)
  • Store in a cool dry place, use immediately after removing from the sheet.
Inactive Ingredients (Inactive ingredients)

Cellulose Gum, Ethylene/VA Copolymer, Polyisobutene, Xanthan Gum, Aloe Barbadensis Leaf Extract, Melaleuca Alternifolia (Tea Tree) Oil, Propylene Glycol, Retinol.

When Using This Product (When using this product)
  • Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.
  • Avoid contact with eyes.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • irritation or redness develops and persists.
Keep Out of Reach of Children. (Keep out of reach of children.)
  • If ingested get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data


Raw Label Data

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