SPL v1
SPL
SPL Set ID 46482b91-f1d5-4f2e-8590-5db31860af7b
Route
TOPICAL
Published
Effective Date 2016-02-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (15 g)
Inactive Ingredients
Green Tea Leaf Ethylhexyl Palmitate

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2016-01-02

Description

Active Ingredient: Glycerin 5.0%

Purpose

Purpose: Skin Protectant


Medication Information

Purpose

Purpose: Skin Protectant

Description

Active Ingredient: Glycerin 5.0%

Usage

Usage: After shower, dry yourself body with a towel and put the lotion on your body.

Warnings

Warnings:

1. Stop usage immediately if any of the below symptoms occur. Continued use could aggravate symptoms, so it is advisable to consult with a dermatologist immediately. 1) Symptoms include but not limited to: red spots, swelling, itchiness. 2) When having the same symptoms as above due to direct sunlight. 2. Do not apply to areas affected by dermatitis, eczema or wounds. 3. Storage and handling: 1) Tightly close lid after each use. 2 Keep out of reach of children 3) Store in a cool dry area, away from sunlight

Active Ingredient

Active Ingredient: Glycerin 5.0%

Inactive Ingredient

Inactive Ingredients: Camellia Sinensis Leaf Extract, Ethylhexyl Palmitate, Kluyveromyces/Lactobacillus/Camellia Japonica Seed Oil Ferment Filtrate, Shea Butter Glycerides, Saccharomyces/Snail Secretion Filtrate Ferment Filtrate, Butylene Glycol, Polymethyl Methacrylate, Cetearyl Alcohol/Cetearyl Glucoside, 1,2-Hexanediol, Cetearyl Alcohol, Stearic Acid, Dimethicone, Tocopheryl Acetate, Sodium Hyaluronate, Allantoin, Aniba Rosaeodora (Rosewood) Wood Oil, Xanthan Gum, Disodium EDTA

Keep Out of Reach of Children

KEEP OUT OF REACH OF CHILDREN

Package Label.principal Display Panel


Structured Label Content

Usage

Usage: After shower, dry yourself body with a towel and put the lotion on your body.

Purpose (PURPOSE)

Purpose: Skin Protectant

Warnings (WARNINGS)

Warnings:

1. Stop usage immediately if any of the below symptoms occur. Continued use could aggravate symptoms, so it is advisable to consult with a dermatologist immediately. 1) Symptoms include but not limited to: red spots, swelling, itchiness. 2) When having the same symptoms as above due to direct sunlight. 2. Do not apply to areas affected by dermatitis, eczema or wounds. 3. Storage and handling: 1) Tightly close lid after each use. 2 Keep out of reach of children 3) Store in a cool dry area, away from sunlight

Active Ingredient (ACTIVE INGREDIENT)

Active Ingredient: Glycerin 5.0%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive Ingredients: Camellia Sinensis Leaf Extract, Ethylhexyl Palmitate, Kluyveromyces/Lactobacillus/Camellia Japonica Seed Oil Ferment Filtrate, Shea Butter Glycerides, Saccharomyces/Snail Secretion Filtrate Ferment Filtrate, Butylene Glycol, Polymethyl Methacrylate, Cetearyl Alcohol/Cetearyl Glucoside, 1,2-Hexanediol, Cetearyl Alcohol, Stearic Acid, Dimethicone, Tocopheryl Acetate, Sodium Hyaluronate, Allantoin, Aniba Rosaeodora (Rosewood) Wood Oil, Xanthan Gum, Disodium EDTA

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

KEEP OUT OF REACH OF CHILDREN

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)


Advanced Ingredient Data


Raw Label Data

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