SPL v1
SPL
SPL Set ID 0bf2ffa3-c87f-1297-e063-6394a90ab057
Route
TOPICAL
Published
Effective Date 2023-12-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Mineral Oil (4.25 g)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2023-12-07
Description

mineral oil

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)

Indications and Usage

1. After cleansing, keep your skin clearly.

2. Carefully remove dots from the film.

3. Stick the patch to target areas of concern and gently press down on the patch for 15~30 seconds

4. Leave in place for 6 hours (Use it during the day or night)

Dosage and Administration

For topical use only

Description

mineral oil

Section 50565-1

Keep out of reach of children

Section 51727-6

water

Section 51945-4

Section 55105-1

skin protectant

for the treatment of acne

Section 55106-9

mineral oil

Structured Label Content

Indications and Usage (34067-9)

1. After cleansing, keep your skin clearly.

2. Carefully remove dots from the film.

3. Stick the patch to target areas of concern and gently press down on the patch for 15~30 seconds

4. Leave in place for 6 hours (Use it during the day or night)

Dosage and Administration (34068-7)

For topical 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)

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

skin protectant

for the treatment of acne

Section 55106-9 (55106-9)

mineral oil

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:27.843576 · Updated: 2026-03-14T23:02:00.533418