drug facts

drug facts
SPL v1
SPL
SPL Set ID e28534d7-42ec-465d-9feb-d3bf8dd1d8fa
Route
topical
Published
Effective Date 2014-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
salicylic acid (0.5 g)
Inactive Ingredients
water niacinamide .alpha.-tocopherol acetate

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2014-11-01
Description

salicylic acid

Medication Information

Warnings and Precautions

For external use only, drinking ban

When using this product

■ keep out of eyes, ears, and mouth. If contact occurs, rinse with plenty of worm or cold water right away and in a serious situation, contact a physician. If swallowing, drink plenty of water and contact a physician

■ Keep out of reach of the children





Active Ingredient

salicylic acid



Indications and Usage

■ Apply only scalp

■ Apply over twice a day and always after wash your hair

■ Apply sufficient quantity to intended part

■ Shake well before use



Dosage and Administration

for external use only

Description

salicylic acid

Section 50565-1

keep out of reach of the children

Section 51727-6

■Purified water ■Ethanol ■Butylene glycol ■Polysolvate 80 ■Hydrogenated lecithin ■Cerium nitrate(III) 6-hydrate ■Acorus calamus root extract ■Angelica gigas root extract ■Panax ginseng root extract ■Glycyrrhiza glabra (licorice) root extract ■Methylparaben ■Monoethanol amine ■D-Panthenol ■Flavor





Section 51945-4
Section 55105-1

scalp protectant (hair growth and loss prevention)



Structured Label Content

Warnings and Precautions (34071-1)

For external use only, drinking ban

When using this product

■ keep out of eyes, ears, and mouth. If contact occurs, rinse with plenty of worm or cold water right away and in a serious situation, contact a physician. If swallowing, drink plenty of water and contact a physician

■ Keep out of reach of the children





Active Ingredient (55106-9)

salicylic acid



Indications and Usage (34067-9)

■ Apply only scalp

■ Apply over twice a day and always after wash your hair

■ Apply sufficient quantity to intended part

■ Shake well before use



Dosage and Administration (34068-7)

for external use only

Section 50565-1 (50565-1)

keep out of reach of the children

Section 51727-6 (51727-6)

■Purified water ■Ethanol ■Butylene glycol ■Polysolvate 80 ■Hydrogenated lecithin ■Cerium nitrate(III) 6-hydrate ■Acorus calamus root extract ■Angelica gigas root extract ■Panax ginseng root extract ■Glycyrrhiza glabra (licorice) root extract ■Methylparaben ■Monoethanol amine ■D-Panthenol ■Flavor





Section 51945-4 (51945-4)
Section 55105-1 (55105-1)

scalp protectant (hair growth and loss prevention)



Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:52.099097 · Updated: 2026-03-14T22:53:53.333843