SPL v2
SPL
SPL Set ID eb616e14-5d23-4ebc-a24d-cc086193c75a
Route
TOPICAL
Published
Effective Date 2018-12-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (0.60 mg)
Inactive Ingredients
Water Glycerin

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, Snail Secretion Filtrate, Glycerin, Butylene Glycol, Hydrogenated Polydecene Cetyl Ethylhexanoate Vegetable Oil Butyrospermum Parkii(Shea Butter) Polyglyceryl-3 Methylglucose Distearate Cetearyl Alcohol Macadamia Ternifolia Seed Oil Hydrogenated Lecithin Trehalose Betaine Althaea Rosea Flower Extract Aloe Barbadensis Leaf Extract Stearic Acid Dimethicone Methylparaben Phenoxyethanol Polyacrylate-13 Polysorbate 20 Polyisobutene Propylparaben Sodium Polyacrylate Sodium Hyaluronate Trisodium EDTA Fragrance

Indications and Usage

Indication and Usage: Apply appropriate amount on the face and gently pat.

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, Snail Secretion Filtrate, Glycerin, Butylene Glycol, Hydrogenated Polydecene Cetyl Ethylhexanoate Vegetable Oil Butyrospermum Parkii(Shea Butter) Polyglyceryl-3 Methylglucose Distearate Cetearyl Alcohol Macadamia Ternifolia Seed Oil Hydrogenated Lecithin Trehalose Betaine Althaea Rosea Flower Extract Aloe Barbadensis Leaf Extract Stearic Acid Dimethicone Methylparaben Phenoxyethanol Polyacrylate-13 Polysorbate 20 Polyisobutene Propylparaben Sodium Polyacrylate Sodium Hyaluronate Trisodium EDTA Fragrance

Indications and Usage (INDICATIONS AND USAGE)

Indication and Usage: Apply appropriate amount on the face and gently pat.

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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