SPL v2
SPL
SPL Set ID bfe9c7fd-1e43-627d-e053-2a95a90ae03c
Route
TOPICAL
Published
Effective Date 2020-04-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (0.008 g) Titanium Dioxide (0.01 g)
Inactive Ingredients
Pinus Densiflora Leaf Indican Sorbitol Maltitol Water Fennel Seed

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2021-04-01
Description

Ethanol, Titanium Dioxide

Medication Information

Warnings and Precautions

Warnings

For external use only.

When using this product • Keep out of eyes • In case of contact with eyes, flush thoroughly with water.

Stop use and ask a doctor ifirritation or redness develop and persist for more than 72 hours.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Indications and Usage

Do not dilute.• Use at strength for maximum effectiveness.• For equipment or products that are difficult to spray, apply liquid to clean gauze or cotton swab.

Dosage and Administration

for external use only

Description

Ethanol, Titanium Dioxide

Section 50565-1

keep out of reach of the children

Section 51727-6

Pinus densiflora callus extract ,Foeniculum vulgare seed extract,Indican,Maltitol,Sorbitol,Water

Section 51945-4

Section 55105-1

Antiseptic

Section 55106-9

Ethanol, Titanium Dioxide

Structured Label Content

Indications and Usage (34067-9)

Do not dilute.• Use at strength for maximum effectiveness.• For equipment or products that are difficult to spray, apply liquid to clean gauze or cotton swab.

Dosage and Administration (34068-7)

for external use only

Warnings and Precautions (34071-1)

Warnings

For external use only.

When using this product • Keep out of eyes • In case of contact with eyes, flush thoroughly with water.

Stop use and ask a doctor ifirritation or redness develop and persist for more than 72 hours.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Section 50565-1 (50565-1)

keep out of reach of the children

Section 51727-6 (51727-6)

Pinus densiflora callus extract ,Foeniculum vulgare seed extract,Indican,Maltitol,Sorbitol,Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antiseptic

Section 55106-9 (55106-9)

Ethanol, Titanium Dioxide

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:31.417325 · Updated: 2026-03-14T22:59:31.191887