Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 3ec99831-f145-4691-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2014-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (8.06 g)
Inactive Ingredients
Shea Butter Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2015-10-01
Description

Glycerin

Medication Information

Warnings and Precautions
  • For external use only
  • When using this product

1. If any one of following symptoms occurs when using cosmetics, stop using it and consult a dermatologist.

A. red spot, swelling, itching, stimulus

B. symptoms mentioned above are caused by sunlight.

2. Do not apply on skin where there is wound, eczema, or irritation.

3. Storage and cautions for handling

A. Close stopper after using.

B. Keep out of reach of children.

C. Keep away from high or low temperature and direct sunlight.

4. This is not a medicinal product. Made of 100% cosmetic ingredients, it is a sensitive-skin care product for all skin types.

Indications and Usage

Apply proper amount to the skin.

Dosage and Administration

for external use only

Description

Glycerin

Section 50565-1

keep out of reach of the children

Section 51727-6

Water, Caprylic/Capric Triglyceride, Butylene Glycol, Butylene Glycol Dicaprylate/Dicaprate, Polyglyceryl-3 Methylglucose Distearate, Squalane, Dipropylene Glycol, Helianthus Annuus (Sunflower) Seed Oil, Beeswax, Cyclopentasiloxane, Sorbitan Stearate, Butyrospermum Parkii (Shea) Butter, Macadamia Integrifolia Seed Oil, Betaine, etc.

Section 51945-4

Section 55105-1

Skin Protectant

Section 55106-9

Glycerin

Structured Label Content

Indications and Usage (34067-9)

Apply proper amount to the skin.

Dosage and Administration (34068-7)

for external use only

Warnings and Precautions (34071-1)
  • For external use only
  • When using this product

1. If any one of following symptoms occurs when using cosmetics, stop using it and consult a dermatologist.

A. red spot, swelling, itching, stimulus

B. symptoms mentioned above are caused by sunlight.

2. Do not apply on skin where there is wound, eczema, or irritation.

3. Storage and cautions for handling

A. Close stopper after using.

B. Keep out of reach of children.

C. Keep away from high or low temperature and direct sunlight.

4. This is not a medicinal product. Made of 100% cosmetic ingredients, it is a sensitive-skin care product for all skin types.

Section 50565-1 (50565-1)

keep out of reach of the children

Section 51727-6 (51727-6)

Water, Caprylic/Capric Triglyceride, Butylene Glycol, Butylene Glycol Dicaprylate/Dicaprate, Polyglyceryl-3 Methylglucose Distearate, Squalane, Dipropylene Glycol, Helianthus Annuus (Sunflower) Seed Oil, Beeswax, Cyclopentasiloxane, Sorbitan Stearate, Butyrospermum Parkii (Shea) Butter, Macadamia Integrifolia Seed Oil, Betaine, etc.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Skin Protectant

Section 55106-9 (55106-9)

Glycerin

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:11.487535 · Updated: 2026-03-14T22:54:29.116843