SPL v2
SPL
SPL Set ID b3f6fc16-4d5e-4178-863e-c3b3db95a99d
Route
TOPICAL
Published
Effective Date 2025-07-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (2 g)
Inactive Ingredients
Water Artemisia Vulgaris Root Bassia Scoparia Fruit Dictamnus Dasycarpus Root Smilax Glabra Tuber Solidago Decurrens Fruiting Top Phellodendron Amurense Bark Euphorbia Fischeriana Root Gleditsia Sinensis Fruit Stemona Tuberosa Root

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-19

Description

Active ingredient: Salicylic Acid 2%


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

Uses:

  • Treats tinea versicolor (a skin condition that causes discolored patches)
  • Helps prevent recurrence
Dosage and Administration

Directions:

  • Wash the affected area with warm water and dry thoroughly.
  • Apply a small amount to the affected area 2–3 times daily.
  • Continue use for at least one week after symptoms disappear to prevent recurrence.
Description

Active ingredient: Salicylic Acid 2%

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

  • If irritation or rash develops, stop use and consult a doctor.
Section 50567-7

When using this product

  • avoid contact with eyes. If contact occurs, rinse thoroughly with water.
  • if irritation or rash develops, stop use and consult a doctor.
Section 50570-1

Do not use:

  • on children under 2 years of age unless directed by a doctor
  • near eyes or mucous membranes
Section 51727-6

Inactive ingredients:

  • Water
  • Artemisia vulgaris extract
  • Kochia scoparia fruit extract
  • Dictamnus dasycarpus root extract
  • Smilax glabra root extract
  • Solidago decurrens fruiting top extract
  • Phellodendron amurense bark extract
  • Euphorbia fischeriana root extract
  • Gleditsia sinensis fruit extract
  • Stemona tuberosa root extract
Section 53413-1

Questions or comments?

Contact us at [email protected]

Section 55105-1
  • Antifungal
Section 55106-9

Active ingredient:

  • Salicylic Acid 2%
Package Label.principal Display Panel


Structured Label Content

Indications and Usage (34067-9)

Uses:

  • Treats tinea versicolor (a skin condition that causes discolored patches)
  • Helps prevent recurrence
Dosage and Administration (34068-7)

Directions:

  • Wash the affected area with warm water and dry thoroughly.
  • Apply a small amount to the affected area 2–3 times daily.
  • Continue use for at least one week after symptoms disappear to prevent recurrence.
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

  • If irritation or rash develops, stop use and consult a doctor.
Section 50567-7 (50567-7)

When using this product

  • avoid contact with eyes. If contact occurs, rinse thoroughly with water.
  • if irritation or rash develops, stop use and consult a doctor.
Section 50570-1 (50570-1)

Do not use:

  • on children under 2 years of age unless directed by a doctor
  • near eyes or mucous membranes
Section 51727-6 (51727-6)

Inactive ingredients:

  • Water
  • Artemisia vulgaris extract
  • Kochia scoparia fruit extract
  • Dictamnus dasycarpus root extract
  • Smilax glabra root extract
  • Solidago decurrens fruiting top extract
  • Phellodendron amurense bark extract
  • Euphorbia fischeriana root extract
  • Gleditsia sinensis fruit extract
  • Stemona tuberosa root extract
Section 53413-1 (53413-1)

Questions or comments?

Contact us at [email protected]

Section 55105-1 (55105-1)
  • Antifungal
Section 55106-9 (55106-9)

Active ingredient:

  • Salicylic Acid 2%
Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)


Advanced Ingredient Data


Raw Label Data

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