Drug Facts

Composition & Product

Active Ingredients

Mineral Oil (8 g)

Inactive Ingredients

Silica Dimethyl Silylate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2017-08-08

Medication Information

Warnings and Precautions

1. If the following symptoms occur after product use, stop using the product immediately and consult a dermatologist (continuous use can exacerbate the symptoms).

1) Occurrence of red spots, swelling, itchiness, and other skin irritation

2) If the symptoms above occur after the application area is exposed to direct sunlight

2. Do not use on open wounds, eczema, and other skin irritations

3. Precaution for Storage and Handling

1) Close the lid after use

2) Keep out of reach of infants and children

3) Do not to store in a place with high/low temperature and exposed to direct sunlight

4. Use as avoiding eye areas.

Indications and Usage

Open the cap, press the button to put suitable amount on the applicator and apply evenly. Keep in a place away from direct sunlight with the cap closed after use

Dosage and Administration

for external use only

Description

mineral oil

Section 50565-1

keep out of reach of the children

Section 51727-6

polybutene, lauryl alcohol, etc

Section 51945-4

Section 55105-1

skin protectant

Section 55106-9

mineral oil

Structured Label Content

Indications and Usage (34067-9)

Open the cap, press the button to put suitable amount on the applicator and apply evenly. Keep in a place away from direct sunlight with the cap closed after use

Dosage and Administration (34068-7)

for external use only

Warnings and Precautions (34071-1)

1. If the following symptoms occur after product use, stop using the product immediately and consult a dermatologist (continuous use can exacerbate the symptoms).

1) Occurrence of red spots, swelling, itchiness, and other skin irritation

2) If the symptoms above occur after the application area is exposed to direct sunlight

2. Do not use on open wounds, eczema, and other skin irritations

3. Precaution for Storage and Handling

1) Close the lid after use

2) Keep out of reach of infants and children

3) Do not to store in a place with high/low temperature and exposed to direct sunlight

4. Use as avoiding eye areas.

Section 50565-1 (50565-1)

keep out of reach of the children

Section 51727-6 (51727-6)

polybutene, lauryl alcohol, etc

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

skin protectant

Section 55106-9 (55106-9)

mineral oil

Advanced Ingredient Data

[{"name": "MINERAL OIL", "unii": "T5L8T28FGP", "classCode": "ACTIB", "strengthNumerator": "8", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "SILICA DIMETHYL SILYLATE", "unii": "EU2PSP0G0W", "classCode": "IACT", "strengthNumerator": "2", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Open the cap, press the button to put suitable amount on the applicator and apply evenly. Keep in a place away from direct sunlight with the cap closed after use", "34068-7": "for external use only", "34071-1": "1. If the following symptoms occur after product use, stop using the product immediately and consult a dermatologist (continuous use can exacerbate the symptoms). 1) Occurrence of red spots, swelling, itchiness, and other skin irritation 2) If the symptoms above occur after the application area is exposed to direct sunlight 2. Do not use on open wounds, eczema, and other skin irritations 3. Precaution for Storage and Handling 1) Close the lid after use 2) Keep out of reach of infants and children 3) Do not to store in a place with high/low temperature and exposed to direct sunlight 4. Use as avoiding eye areas.", "50565-1": "keep out of reach of the children", "51727-6": "polybutene, lauryl alcohol, etc", "55105-1": "skin protectant", "55106-9": "mineral oil"}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information