50a3670a-008c-09c9-e054-00144ff8d46c

SPL v1
SPL
SPL Set ID 50a3670a-008c-09c9-e054-00144ff8d46c
Route
topical
Published
Effective Date 2017-05-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
stearic acid (16 g)
Inactive Ingredients
water butylene glycol

Identifiers & Packaging

Marketing Status
unapproved drug other active Since 2017-05-26
Description

Stearic Acid

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.

Active Ingredient

Stearic Acid

Indications and Usage
  • Wet the face with warm water.
  • Apply to the face and around the neck with gently massaging action for abount 1~2 minutes.
  • Rinse thoroughly with warm water.
Dosage and Administration

for external use only

Description

Stearic Acid

Section 50565-1

Keep out of reach of the children

Section 51727-6

Water, Butylene Glycol, Etc

Section 51945-4

Section 55105-1

Skin Protectant - Cleasing

Structured Label Content

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.

Active Ingredient (55106-9)

Stearic Acid

Indications and Usage (34067-9)
  • Wet the face with warm water.
  • Apply to the face and around the neck with gently massaging action for abount 1~2 minutes.
  • Rinse thoroughly with warm water.
Dosage and Administration (34068-7)

for external use only

Section 50565-1 (50565-1)

Keep out of reach of the children

Section 51727-6 (51727-6)

Water, Butylene Glycol, Etc

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Skin Protectant - Cleasing

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:21.723726 · Updated: 2026-03-14T22:54:44.018094