Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 414f16da-1644-5f0b-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2009-09-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (0.008 g)
Inactive Ingredients
Shea Butter Aloe Vera Leaf Medium-chain Triglycerides

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-10-01
Description

Glycerin

Purpose

Skin protectant

Medication Information

Warnings and Precautions

1. Stop using the product if there are any of the following abnormal symptoms appearing after use and consult with your dermatologist as continued use can worsen the symptoms.

1) If there are red spots, swelling, itchiness, or irritation

2) If the above symptoms appear around the skin to which the product has been applied after being exposed to direct sunlight.

2. Do not apply the product to any parts of the skin with wound, eczema, or dermatitis.

3. If it gets into eye, wash the eye with clean water immediately.

4. Those who are allergic to certain medicinal herb, such as pollen and tangerine, must stop using the product if they experience hypersensitivity.

5. Precautions on storage and handling

1) Make sure to close the cap after use.

2) Keep out of the reach of children.

3) Do not keep the product in a hot or cold place or a place getting direct sunlight.

Indications and Usage

  • Apply to baby's face and body evenly after a bath or washing.

  • Apply to dry, rough-textured area repeatedly.

  • Use with Truezyme Baby Shampoo & Body Wash for better results.

Purpose

Skin protectant

Dosage and Administration

For external use only

Description

Glycerin

Section 50565-1

Keep out of reach of children.

Section 51945-4

Active Ingredient

Glycerin

Inactive Ingredients:

Sea Water, Caprylic/Capric Triglyceride, Propanediol, Aloe Barbadensis Leaf Extract, Butyrospermum Parkii (Shea) Butter, etc.

Structured Label Content

Indications and Usage (34067-9)

  • Apply to baby's face and body evenly after a bath or washing.

  • Apply to dry, rough-textured area repeatedly.

  • Use with Truezyme Baby Shampoo & Body Wash for better results.

Dosage and Administration (34068-7)

For external use only

Warnings and Precautions (34071-1)

1. Stop using the product if there are any of the following abnormal symptoms appearing after use and consult with your dermatologist as continued use can worsen the symptoms.

1) If there are red spots, swelling, itchiness, or irritation

2) If the above symptoms appear around the skin to which the product has been applied after being exposed to direct sunlight.

2. Do not apply the product to any parts of the skin with wound, eczema, or dermatitis.

3. If it gets into eye, wash the eye with clean water immediately.

4. Those who are allergic to certain medicinal herb, such as pollen and tangerine, must stop using the product if they experience hypersensitivity.

5. Precautions on storage and handling

1) Make sure to close the cap after use.

2) Keep out of the reach of children.

3) Do not keep the product in a hot or cold place or a place getting direct sunlight.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51945-4 (51945-4)

Purpose

Skin protectant

Active Ingredient (Active ingredient)

Glycerin

Inactive Ingredients: (Inactive ingredients:)

Sea Water, Caprylic/Capric Triglyceride, Propanediol, Aloe Barbadensis Leaf Extract, Butyrospermum Parkii (Shea) Butter, etc.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:56:12.775426 · Updated: 2026-03-14T22:54:32.145936