SPL v8
SPL
SPL Set ID 6c5adc3c-9d45-449a-ad42-f9571851cd18
Route
TOPICAL
Published
Effective Date 2025-06-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (170 mg)
Inactive Ingredients
Menthol Coptis Chinensis Root Phellodendron Chinensis Bark Acorus Gramineus Root Alcohol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-02
Description

Active ingredient: Salicylic Acid 17%

Medication Information

Warnings and Precautions

For external use only

Indications and Usage

Uses For the removal of common

  • warts
  • corns
  • calluses
Dosage and Administration

Directions:

  • Clean and dry the affected area
  • Apply a thin layer once or twice daily
  • Do not apply to open wounds or infected skin
Description

Active ingredient: Salicylic Acid 17%

Section 50565-1

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if

  • excessive irritation occurs.
Section 50567-7

When using this product

Avoid contact with eyes

Section 50570-1

Do not use:

  • on mucous membranes, or broken skin
  • Do not apply to open wounds or infected skin
Section 51727-6

Inactive ingredients:

  • Menthol
  • Coptis chinensis extract (COPTIS CHINENSIS ROOT)
  • Phellodendron extract (PHELLODENDRON CHINENSIS BARK)
  • Acorus gramineus extract (ACORUS GRAMINEUS ROOT)
  • Ethanol (ALCOHOL)
  • Water (WATER)
Section 53413-1

Questions or comments?

[email protected]

Section 55105-1
  • Wart, corn, and callus remover
Section 55106-9

Active ingredient:

  • Salicylic Acid 17%
Section 60561-8

Other information:

  • Store at room temperature
  • Avoid heat and direct sunlight
Package Label.principal Display Panel

Available in 7 mL, 8 mL, 9 mL, and 10 mL tubes. All packages look the same externally, with the only variation being fill volume.

Structured Label Content

Indications and Usage (34067-9)

Uses For the removal of common

  • warts
  • corns
  • calluses
Dosage and Administration (34068-7)

Directions:

  • Clean and dry the affected area
  • Apply a thin layer once or twice daily
  • Do not apply to open wounds or infected skin
Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • excessive irritation occurs.
Section 50567-7 (50567-7)

When using this product

Avoid contact with eyes

Section 50570-1 (50570-1)

Do not use:

  • on mucous membranes, or broken skin
  • Do not apply to open wounds or infected skin
Section 51727-6 (51727-6)

Inactive ingredients:

  • Menthol
  • Coptis chinensis extract (COPTIS CHINENSIS ROOT)
  • Phellodendron extract (PHELLODENDRON CHINENSIS BARK)
  • Acorus gramineus extract (ACORUS GRAMINEUS ROOT)
  • Ethanol (ALCOHOL)
  • Water (WATER)
Section 53413-1 (53413-1)

Questions or comments?

[email protected]

Section 55105-1 (55105-1)
  • Wart, corn, and callus remover
Section 55106-9 (55106-9)

Active ingredient:

  • Salicylic Acid 17%
Section 60561-8 (60561-8)

Other information:

  • Store at room temperature
  • Avoid heat and direct sunlight
Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

Available in 7 mL, 8 mL, 9 mL, and 10 mL tubes. All packages look the same externally, with the only variation being fill volume.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:21.940820 · Updated: 2026-03-14T23:09:06.809873