Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID 024f9299-ee6c-48e3-89e7-96b7db060c30

Route

TOPICAL

Published

Effective Date 2024-06-20

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Salicylic Acid (18.5 mg)

Inactive Ingredients

Water Alcohol Aminomethylpropanol Ascorbyl Glucoside Madecassoside Niacinamide Polyoxyl 40 Hydrogenated Castor Oil Polysorbate 21 Hyaluronate Sodium

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-11-15

Description

Salicylic acid 1.85%

Purpose

Antidandruff

Medication Information

Purpose

Antidandruff

Description

Salicylic acid 1.85%

Uses

controls the symptoms of dandruff
fights recurrence of the symptoms of dandruff
controls scalp itching associated with dandruff

Section 51945-4

Warnings

For external use only

Directions

part dry or damp hair in 4 sections
apply 5 doses to each section
massage product into scalp
apply to affected areas one to four times daily or as directed by a doctor

Active Ingredient

Salicylic acid 1.85%

Inactive Ingredients

water, alcohol denat., aminomethyl propanol, ascorbyl glucoside, madecassoside, niacinamide, PEG-40 hydrogenated castor oil, polysorbate 21, sodium hyaluronate, fragrance

Questions Or Comments?

1-877-378-4249

Monday-Friday (9 a.m. - 5 p.m. EST)

When Using This Product

Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

Stop Use and Ask A Doctor If

condition worsens or does not improve after regular use of this product as directed

Keep Out of Reach of Children.

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

Structured Label Content

Uses

controls the symptoms of dandruff
fights recurrence of the symptoms of dandruff
controls scalp itching associated with dandruff

Section 51945-4 (51945-4)

Purpose

Antidandruff

Warnings

For external use only

Directions

part dry or damp hair in 4 sections
apply 5 doses to each section
massage product into scalp
apply to affected areas one to four times daily or as directed by a doctor

Active Ingredient (Active ingredient)

Salicylic acid 1.85%

Inactive Ingredients (Inactive ingredients)

water, alcohol denat., aminomethyl propanol, ascorbyl glucoside, madecassoside, niacinamide, PEG-40 hydrogenated castor oil, polysorbate 21, sodium hyaluronate, fragrance

Questions Or Comments? (Questions or comments?)

1-877-378-4249

Monday-Friday (9 a.m. - 5 p.m. EST)

When Using This Product (When using this product)

Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

condition worsens or does not improve after regular use of this product as directed

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Advanced Ingredient Data

[{"name": "SALICYLIC ACID", "unii": "O414PZ4LPZ", "classCode": "ACTIB", "strengthNumerator": "18.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "AMINOMETHYLPROPANOL", "unii": "LU49E6626Q", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ASCORBYL GLUCOSIDE", "unii": "2V52R0NHXW", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MADECASSOSIDE", "unii": "CQ2F5O6YIY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "NIACINAMIDE", "unii": "25X51I8RD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYOXYL 40 HYDROGENATED CASTOR OIL", "unii": "7YC686GQ8F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 21", "unii": "59IO08SBZU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYALURONATE SODIUM", "unii": "YSE9PPT4TH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "controls the symptoms of dandruff fights recurrence of the symptoms of dandruff controls scalp itching associated with dandruff", "Purpose": "Antidandruff", "Warnings": "For external use only", "Directions": "part dry or damp hair in 4 sections apply 5 doses to each section massage product into scalp apply to affected areas one to four times daily or as directed by a doctor ", "Active ingredient": "Salicylic acid 1.85%", "Inactive ingredients": "water, alcohol denat., aminomethyl propanol, ascorbyl glucoside, madecassoside, niacinamide, PEG-40 hydrogenated castor oil, polysorbate 21, sodium hyaluronate, fragrance", "Questions or comments?": "1-877-378-4249 Monday-Friday (9 a.m. - 5 p.m. EST)", "When using this product": "Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water. ", "Stop use and ask a doctor if": "condition worsens or does not improve after regular use of this product as directed", "Keep out of reach of children.": "If swallowed, get medical help or contact a Poison Control Center right away."}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:04:24.969528 · Updated: 2026-03-14T23:05:07.358425