Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 44b29200-8560-0405-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2016-02-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Jojoba Oil (0.01 g) Aloe Vera Leaf (1 g) Shea Butter (3.5 g)
Inactive Ingredients
Water Butylene Glycol Urea Glycerin

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2016-12-01

Description

Butyrospermum Parkii(Shea Butter), Aloe Barbadensis Leaf Extract, Simmondsia Chinensis (Jojoba) Seed Oil


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

Moisturizing Socks

1. Rinse feet thoroughly and completely dry them to remove any moisture.

2. Insert feet in the moisturizing socks and make sure the contents of the liquid are inside.

3. While wearing the moisturizing socks, massage feet to absorb all the liquid.

4. After 20 to 30 minutes, remove moisturizing socks and massage in the remaining liquid for long-lasting hydration.

Moisturizing Gloves

1. Wash hands thoroughly and completely dry them to remove any moisture.

2. Open and put hands in the hand moisturizing treatment and make sure the contents of the liquid makeup is inside.

3. While wearing the hand moisturizing treatment, massage them to thoroughly absorb all the moisture.

4. After 20-30 minutes remove the hand moisturizing treatment and softly pat down the remaining contents for better absorption.

Dosage and Administration

for external use only



Description

Butyrospermum Parkii(Shea Butter), Aloe Barbadensis Leaf Extract, Simmondsia Chinensis (Jojoba) Seed Oil

Section 50565-1

keep out of reach of the children

Section 51727-6

Water, Glycerin, Butylene Glycol, Urea, Betaine, Collagen, Etc.

Section 51945-4

Section 55105-1

Skin protectant

Section 55106-9

Butyrospermum Parkii(Shea Butter), Aloe Barbadensis Leaf Extract, Simmondsia Chinensis (Jojoba) Seed Oil


Structured Label Content

Indications and Usage (34067-9)

Moisturizing Socks

1. Rinse feet thoroughly and completely dry them to remove any moisture.

2. Insert feet in the moisturizing socks and make sure the contents of the liquid are inside.

3. While wearing the moisturizing socks, massage feet to absorb all the liquid.

4. After 20 to 30 minutes, remove moisturizing socks and massage in the remaining liquid for long-lasting hydration.

Moisturizing Gloves

1. Wash hands thoroughly and completely dry them to remove any moisture.

2. Open and put hands in the hand moisturizing treatment and make sure the contents of the liquid makeup is inside.

3. While wearing the hand moisturizing treatment, massage them to thoroughly absorb all the moisture.

4. After 20-30 minutes remove the hand moisturizing treatment and softly pat down the remaining contents for better absorption.

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)

Water, Glycerin, Butylene Glycol, Urea, Betaine, Collagen, Etc.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Skin protectant

Section 55106-9 (55106-9)

Butyrospermum Parkii(Shea Butter), Aloe Barbadensis Leaf Extract, Simmondsia Chinensis (Jojoba) Seed Oil


Advanced Ingredient Data


Raw Label Data

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