Salicylic Acid Patches

Salicylic Acid Patches
SPL v1
SPL
SPL Set ID 5c5500ab-ba06-4be5-8943-511c1dc58468
Route
TOPICAL
Published
Effective Date 2022-09-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (0.5 mg)
Inactive Ingredients
Carboxymethylcellulose Sodium Styrene Hydrogenated C6-20 Polyolefin (100 Cst) Mineral Oil Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Polyisobutylene (1300 Mw) Propylene Glycol Tea Tree Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2022-09-15

Description

Salicylic Acid 0.5%


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

Use for the treatment of acne

Dosage and Administration

Directions

  • Sensitivity 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 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 hours remove by gently peeling back and discarding.
  • Cleanse the treated area and apply another patch if desired.
Description

Salicylic Acid 0.5%

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor

  • if irritation or redness develops and persists.
Section 50567-7
  • Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of skin. If this occurs, only one medication should be used unless directed by a doctor.
  • Avoid contact with eyes.
Section 50570-1
  • On irritated or sunburnt skin.
Section 51727-6

Cellulose Gum, Styrene/Isoprene Copolymer, Hydrogenated Poly (C6-20 Olefin), Paraffinum Liquidum, Pentaerthrityl Tetra-Di-t-Butyl Hydroxyhydrocinnamate, Polyisobutene, Propylene Glycol, Melaleuca Alternifolia Leaf Oil.

Section 51945-4

Section 53413-1

Question? 1-800-548-4097

Section 55105-1

Acne Treatment

Section 55106-9

Salicylic Acid 0.5%

Section 60561-8

Other

  • Store in a cool dry place. Use immediately after removing from the sheet.

Structured Label Content

Indications and Usage (34067-9)

Use for the treatment of acne

Dosage and Administration (34068-7)

Directions

  • Sensitivity 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 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 hours remove by gently peeling back and discarding.
  • Cleanse the treated area and apply another patch if desired.
Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor

  • if irritation or redness develops and persists.
Section 50567-7 (50567-7)
  • Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of skin. If this occurs, only one medication should be used unless directed by a doctor.
  • Avoid contact with eyes.
Section 50570-1 (50570-1)
  • On irritated or sunburnt skin.
Section 51727-6 (51727-6)

Cellulose Gum, Styrene/Isoprene Copolymer, Hydrogenated Poly (C6-20 Olefin), Paraffinum Liquidum, Pentaerthrityl Tetra-Di-t-Butyl Hydroxyhydrocinnamate, Polyisobutene, Propylene Glycol, Melaleuca Alternifolia Leaf Oil.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Question? 1-800-548-4097

Section 55105-1 (55105-1)

Acne Treatment

Section 55106-9 (55106-9)

Salicylic Acid 0.5%

Section 60561-8 (60561-8)

Other

  • Store in a cool dry place. Use immediately after removing from the sheet.

Advanced Ingredient Data


Raw Label Data

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