Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID f6198b38-314f-438e-9df3-bcd74bf21080
Route
TOPICAL
Published
Effective Date 2011-04-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (0.005 mL) Niacinamide (0.003 mL)
Inactive Ingredients
Water Butylene Glycol Polysorbate 80 Hydrogenated Soybean Lecithin Acorus Calamus Root Angelica Gigas Root Panax Ginseng Root Water Glycyrrhiza Glabra Methylparaben Monoethanolamine Panthenol

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2010-04-08
Description

active ingredient: salicylic acid, niacinamide, tocopherol acetate

Medication Information

Warnings and Precautions
- for external use only

- do not swallow

- keep out of eyes, ears and mouth
Indications and Usage
- shake well before use

- apply sufficient quantity to intended part

Dosage and Administration
- apply only for scalp

- apply more than twice a day after washing hair

Description

active ingredient: salicylic acid, niacinamide, tocopherol acetate

Section 50565-1
keep out of reach of the children
Section 51727-6
inactive ingredient:  d-water, ethanol, butylene glycol, polysorbate 80, hydrogenated lecithin, cerium nitrate(III) 6-hydrate, acorus calamus root extract, angelica gigas root extract, panax ginseng root extract, glycyrrhiza glabra root extract, methylparaben, monoethanol amine, d-panthenol, flavor

Section 51945-4
Section 55105-1
scalp protectant (hair growth and loss prevention)
Section 55106-9
active ingredient: salicylic acid, niacinamide, tocopherol acetate

Structured Label Content

Indications and Usage (34067-9)
- shake well before use

- apply sufficient quantity to intended part

Dosage and Administration (34068-7)
- apply only for scalp

- apply more than twice a day after washing hair

Warnings and Precautions (34071-1)
- for external use only

- do not swallow

- keep out of eyes, ears and mouth
Section 50565-1 (50565-1)
keep out of reach of the children
Section 51727-6 (51727-6)
inactive ingredient:  d-water, ethanol, butylene glycol, polysorbate 80, hydrogenated lecithin, cerium nitrate(III) 6-hydrate, acorus calamus root extract, angelica gigas root extract, panax ginseng root extract, glycyrrhiza glabra 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)
Section 55106-9 (55106-9)
active ingredient: salicylic acid, niacinamide, tocopherol acetate

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:14.114079 · Updated: 2026-03-14T22:52:37.403989