SPL v2
SPL
SPL Set ID a909f7e2-21ac-cf9e-e053-2995a90a6f90
Route
TOPICAL
Published
Effective Date 2020-06-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (0.3 g)
Inactive Ingredients
Copper High Density Polyethylene

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2020-06-27
Description

titanium dioxide

Medication Information

Warnings and Precautions

For external use only

When using this product

■ if following abnormal symptoms persist, discontinue use

Irritation around the eyes, ears, mucous membranes, including the mouth, under the skin irritation and rashes

■ Stop immediately and consult a doctor if you experience

1) Hypersensitivity symptoms such as erythema, itching and dermatitis.

2) Skin Irritation

3) Following Instructions when using medication

(1) For external use only (Do not use internally)

(2) Avoid getting into the eyes (if contact occurs, wash well with clean water)

■ Do not use the product for a long time in the same area as swelling, inflammation or sickness may occur due to absorption through the skin.

It is not recommended to use this one areas that have been medically treated with a cast or bandage.

Indications and Usage

apply proper amount where needed

Dosage and Administration

For external use only

Description

titanium dioxide

Section 50565-1

Keep out of reach of children

Section 51727-6

polyethylene, copper

Section 51945-4

Section 55105-1

Antibacterial

Section 55106-9

titanium dioxide

Structured Label Content

Indications and Usage (34067-9)

apply proper amount where needed

Dosage and Administration (34068-7)

For external use only

Warnings and Precautions (34071-1)

For external use only

When using this product

■ if following abnormal symptoms persist, discontinue use

Irritation around the eyes, ears, mucous membranes, including the mouth, under the skin irritation and rashes

■ Stop immediately and consult a doctor if you experience

1) Hypersensitivity symptoms such as erythema, itching and dermatitis.

2) Skin Irritation

3) Following Instructions when using medication

(1) For external use only (Do not use internally)

(2) Avoid getting into the eyes (if contact occurs, wash well with clean water)

■ Do not use the product for a long time in the same area as swelling, inflammation or sickness may occur due to absorption through the skin.

It is not recommended to use this one areas that have been medically treated with a cast or bandage.

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

polyethylene, copper

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antibacterial

Section 55106-9 (55106-9)

titanium dioxide

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:03.459097 · Updated: 2026-03-14T22:57:25.927839