8427de4d-7883-4cdc-b048-5474a06ace23

SPL v1
SPL
SPL Set ID 8427de4d-7883-4cdc-b048-5474a06ace23
Route
topical
Published
Effective Date 2015-03-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
glycerin (6 g)
Inactive Ingredients
water arbutin

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2014-05-01

Purpose

PURPOSE: Skin Protectant

Description

Active Ingredient: Glycerin 20%


Medication Information

Warnings

Warnings: 1. In case of having following symptoms after using this, you're advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist. 1) In case of having problems such as red rash, swollenness, itching, stimulation during usage. 2) In case of having the same symptoms above on the part you put this product on by direct sunlight. 2. You are banned to use it on the part where you have a scar, eczema, or dermatitis. 3. In case of getting it into your eyes, you have to wash it immediately.

Purpose

PURPOSE: Skin Protectant

Description

Active Ingredient: Glycerin 20%

Active Ingredient

Active Ingredient: Glycerin 20%

Inactive Ingredient

Inactive Ingredients: Water, Vegetable Oil, Cyclopentasiloxane, Cyclohexasiloxane, Caprylic/Capric Triglyceride, Tribehenin PEG-20 Esters, Octyldodecanol, Citrus Aurantium Dulcis (Orange) Fruit Extract (2%)&Butylene Glycol (5%)& Water(93%), Butyrospermum Parkii(Shea Butter), Arbutin, Dipropylene Glycol, Citrus Medica Limonum (Lemon) Fruit Extract(2%) & Butylene Glycol(5%)&Water(93%), Dimethicone, Citrus Junos Fruit Extract(2%)& Propylene Glycol(10%) & Water(88%), Glyceryl Stearate, Fragrance, Phenoxyethanol, Methylparaben, Propylparaben, Xanthan Gum, Carbomer, Triethanolamine, CI 19140, CI 17200

Indications & Usage

INDICATIONS AND USAGE: Clean the hands, remove moist, apply sufficient amount on the hands. Could use on elbows and knees.

Dosage & Administration

DOSAGE AND ADMINISTRATION: Take an adequate amount of this product.

Keep Out of Reach of Children

Keep out of reach of children: Keep out of reach of babies and children

Package Label.principal Display Panel

Image of carton


Structured Label Content

Warnings (WARNINGS)

Warnings: 1. In case of having following symptoms after using this, you're advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist. 1) In case of having problems such as red rash, swollenness, itching, stimulation during usage. 2) In case of having the same symptoms above on the part you put this product on by direct sunlight. 2. You are banned to use it on the part where you have a scar, eczema, or dermatitis. 3. In case of getting it into your eyes, you have to wash it immediately.

Purpose (PURPOSE)

PURPOSE: Skin Protectant

Active Ingredient (ACTIVE INGREDIENT)

Active Ingredient: Glycerin 20%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive Ingredients: Water, Vegetable Oil, Cyclopentasiloxane, Cyclohexasiloxane, Caprylic/Capric Triglyceride, Tribehenin PEG-20 Esters, Octyldodecanol, Citrus Aurantium Dulcis (Orange) Fruit Extract (2%)&Butylene Glycol (5%)& Water(93%), Butyrospermum Parkii(Shea Butter), Arbutin, Dipropylene Glycol, Citrus Medica Limonum (Lemon) Fruit Extract(2%) & Butylene Glycol(5%)&Water(93%), Dimethicone, Citrus Junos Fruit Extract(2%)& Propylene Glycol(10%) & Water(88%), Glyceryl Stearate, Fragrance, Phenoxyethanol, Methylparaben, Propylparaben, Xanthan Gum, Carbomer, Triethanolamine, CI 19140, CI 17200

Indications & Usage (INDICATIONS & USAGE)

INDICATIONS AND USAGE: Clean the hands, remove moist, apply sufficient amount on the hands. Could use on elbows and knees.

Dosage & Administration (DOSAGE & ADMINISTRATION)

DOSAGE AND ADMINISTRATION: Take an adequate amount of this product.

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

Keep out of reach of children: Keep out of reach of babies and children

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

Image of carton


Advanced Ingredient Data


Raw Label Data

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