SPL v2
SPL
SPL Set ID 5073bdad-2702-4abf-8960-e3582ca131eb
Route
TOPICAL
Published
Effective Date 2018-12-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (1 mg)
Inactive Ingredients
Water Betaine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-06-01

Description

Active Ingredients: Dimethicone 1%

Purpose

Purpose: Skin Protectant


Medication Information

Purpose

Purpose: Skin Protectant

Description

Active Ingredients: Dimethicone 1%

Warnings

Warning:

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.

Active Ingredient

Active Ingredients: Dimethicone 1%

Inactive Ingredient

Inactive Ingredients:

Water,Sodium Laureth Sulfate,Cocamidopropyl,Betaine,Disodium Cocoamphodipropionate,PEG-7 Glyceryl Cocoate,Acrylates Copolymer,Acrylates/Beheneth-25 Methacrylate Copolymer,Methyl Perfluorobutyl Ether,Methyl Perfluoroisobutyl Ether,Polyhydroxystearic Acid,Ethylhexyl Isononanoate,Sodium Cocamidopropyl PG-Dimonium Chloride Phosphate,Isononyl Isononanoate,Snail Secretion Filtrate, Glycerin,Psidium Guajava Fruit Extract,Litchi Chinensis Fruit Extract,Mangifera Indica (Mango) Fruit Extract, Citrus Paradisi (Grapefruit) Fruit Extract,Nephelium Lappaceum Extract,Carica Papaya (Papaya) Fruit Extract,Fragrance,Potassium Alum,Pearl Powder,Xanthan Gum,Potassium Hydroxide,Trisodium EDTA, Papain,Methylchloroisothiazolinone,Methylisothiazolinone

Indications and Usage

Indication and Usage: After cleansing, pump three times and roll on the dry face avoiding eye area. Rinse off with lukewarm water after 5 minutes.

Dosage and 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


Structured Label Content

Purpose (PURPOSE)

Purpose: Skin Protectant

Warnings (WARNINGS)

Warning:

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.

Active Ingredient (ACTIVE INGREDIENT)

Active Ingredients: Dimethicone 1%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive Ingredients:

Water,Sodium Laureth Sulfate,Cocamidopropyl,Betaine,Disodium Cocoamphodipropionate,PEG-7 Glyceryl Cocoate,Acrylates Copolymer,Acrylates/Beheneth-25 Methacrylate Copolymer,Methyl Perfluorobutyl Ether,Methyl Perfluoroisobutyl Ether,Polyhydroxystearic Acid,Ethylhexyl Isononanoate,Sodium Cocamidopropyl PG-Dimonium Chloride Phosphate,Isononyl Isononanoate,Snail Secretion Filtrate, Glycerin,Psidium Guajava Fruit Extract,Litchi Chinensis Fruit Extract,Mangifera Indica (Mango) Fruit Extract, Citrus Paradisi (Grapefruit) Fruit Extract,Nephelium Lappaceum Extract,Carica Papaya (Papaya) Fruit Extract,Fragrance,Potassium Alum,Pearl Powder,Xanthan Gum,Potassium Hydroxide,Trisodium EDTA, Papain,Methylchloroisothiazolinone,Methylisothiazolinone

Indications and Usage (INDICATIONS AND USAGE)

Indication and Usage: After cleansing, pump three times and roll on the dry face avoiding eye area. Rinse off with lukewarm water after 5 minutes.

Dosage and Administration (DOSAGE AND 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)


Advanced Ingredient Data


Raw Label Data

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