Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 44c258e6-9c85-56f2-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2015-11-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (1 g)
Inactive Ingredients
Water Butylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-12-29

Description

dimethicone


Medication Information

Warnings and Precautions

1. Do not use in the following cases(Eczema and scalp wounds)

2.Side Effects

1)Due to the use of this druf if rash, irritation, itching and symptopms of hypersnesitivity occur dicontinue use and consult your phamacisr or doctor

3.General Precautions

1)If in contact with the eyes, wash out thoroughty with water If the symptoms are servere, seek medical advice immediately

2)This product is for exeternal use only. Do not use for internal use

4.Storage and handling precautions

1)If possible, avoid direct sunlight and store in cool and area of low humidity

2)In order to maintain the quality of the product and avoid misuse

3)Avoid placing the product near fire and store out in reach of children

Indications and Usage

apply proper amount to the skin

Dosage and Administration

for external use only



Description

dimethicone

Section 50565-1

keep out of reach of the children



Section 51727-6

Water, Beeswax, Butylene Glycol, Butylene Glycol Dicaprylate/Dicaprate, Cetyl Alcohol, Cetearyl Alcohol, Betaine, 1,2-Hexanedioln, Stearic Acid, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Polysorbate60, Sorbitan Stearate,Vanillyl Butyl Ether, Arginine, PEG-100 Stearate, Portulaca Oleracea Extract, Xanthan Gum, Glyceryl Stearate, Cetearyl Glucoside, p-Anisic Acid, Glyceryl Caprylate, Tocopheryl Acetate, Acetyl Glucosamine, Dimethyl Sulfone, Carbomer, Lavandula Angustifolia (Lavender) Oil, Centella Asiatica Extract, Cucurbita Pepo (Pumpkin) Fruit Extract, Opuntia Ficus-Indica Stem Extract, Hydrogenated Lecithin, Disodium EDTA, Polygonum Cuspidatum Root Extract, Scutellaria Baicalensis Root Extract, Camellia Sinensis Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Lactic Acid, Chamomilla Recutita (Matricaria) Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Cholesterol, Punica Granatum Flower Extract, Althaea Rosea Flower Extract, Prunus Mume Flower Extract, Nelumbo Nucifera Flower Extract, Althaea Rosea Root Extract, Prunus Mume Root Extract, Nelumbo Nucifera Root Extract, Lactobacillus Ferment

Section 51945-4
Section 55105-1

skin protectant



Section 55106-9

dimethicone




Structured Label Content

Indications and Usage (34067-9)

apply proper amount to the skin

Dosage and Administration (34068-7)

for external use only



Warnings and Precautions (34071-1)

1. Do not use in the following cases(Eczema and scalp wounds)

2.Side Effects

1)Due to the use of this druf if rash, irritation, itching and symptopms of hypersnesitivity occur dicontinue use and consult your phamacisr or doctor

3.General Precautions

1)If in contact with the eyes, wash out thoroughty with water If the symptoms are servere, seek medical advice immediately

2)This product is for exeternal use only. Do not use for internal use

4.Storage and handling precautions

1)If possible, avoid direct sunlight and store in cool and area of low humidity

2)In order to maintain the quality of the product and avoid misuse

3)Avoid placing the product near fire and store out in reach of children

Section 50565-1 (50565-1)

keep out of reach of the children



Section 51727-6 (51727-6)

Water, Beeswax, Butylene Glycol, Butylene Glycol Dicaprylate/Dicaprate, Cetyl Alcohol, Cetearyl Alcohol, Betaine, 1,2-Hexanedioln, Stearic Acid, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Polysorbate60, Sorbitan Stearate,Vanillyl Butyl Ether, Arginine, PEG-100 Stearate, Portulaca Oleracea Extract, Xanthan Gum, Glyceryl Stearate, Cetearyl Glucoside, p-Anisic Acid, Glyceryl Caprylate, Tocopheryl Acetate, Acetyl Glucosamine, Dimethyl Sulfone, Carbomer, Lavandula Angustifolia (Lavender) Oil, Centella Asiatica Extract, Cucurbita Pepo (Pumpkin) Fruit Extract, Opuntia Ficus-Indica Stem Extract, Hydrogenated Lecithin, Disodium EDTA, Polygonum Cuspidatum Root Extract, Scutellaria Baicalensis Root Extract, Camellia Sinensis Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Lactic Acid, Chamomilla Recutita (Matricaria) Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Cholesterol, Punica Granatum Flower Extract, Althaea Rosea Flower Extract, Prunus Mume Flower Extract, Nelumbo Nucifera Flower Extract, Althaea Rosea Root Extract, Prunus Mume Root Extract, Nelumbo Nucifera Root Extract, Lactobacillus Ferment

Section 51945-4 (51945-4)
Section 55105-1 (55105-1)

skin protectant



Section 55106-9 (55106-9)

dimethicone




Advanced Ingredient Data


Raw Label Data

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