drug facts

drug facts
SPL v1
SPL
SPL Set ID 7e9ae075-068d-85fd-e053-2a91aa0ade74
Route
topical
Published
Effective Date 2019-01-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dimethicone (8 g)
Inactive Ingredients
water butylene glycol

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2019-01-04

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

Active Ingredient

dimethicone

Indications and Usage

Apply to the skin and gently rub it to absorb it

Dosage and Administration

for topical use only

Description

dimethicone

Section 50565-1

keep out of reach of the children

Section 51727-6

Water, Butylene Glycol, Bentonite, SparassisCrispa Extract, Betaine, Methyl Gluceth-20, Isononyl Isononanoate, Cyclopentasiloxane, Glycerin, Niacinamide, Hydrogenated Poly(C6-14 Olefin), Caprylic/Capric Triglyceride, Cyclohexasiloxane, Cetearyl Alcohol, Boswellia Serrata Extract, CentellaAsiatica Extract, Dioscorea Japonica Root Extract, Portulaca Oleracea Extract, Caprylyl Glycol, Dimethicone/Vinyl DimethiconeCrosspolymer, 1,2-Hexanediol, Sodium Polyacrylate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tocopheryl Acetate, Tromethamine, Carbomer, Sodium Hyaluronate, Dipotassium Glycyrrhizate, Ethylhexylglycerin, Adenosine, Hydrolyzed Corn Starch, XANTHAN GUM, Disodium EDTA, Trideceth-6, PEG/PPG-18/18 Dimethicone, Beta-Glucan, Sucrose, PEG-100 Stearate, Glyceryl Stearate, Cetearyl Glucoside, SorbitanOlivate, SorbitanSesquioleate, Polysorbate 60, Stearic Acid, Fragrance

Section 51945-4

Section 55105-1

Problematic nails and skin improvement moisturizer


Structured Label Content

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

Active Ingredient (55106-9)

dimethicone

Indications and Usage (34067-9)

Apply to the skin and gently rub it to absorb it

Dosage and Administration (34068-7)

for topical use only

Section 50565-1 (50565-1)

keep out of reach of the children

Section 51727-6 (51727-6)

Water, Butylene Glycol, Bentonite, SparassisCrispa Extract, Betaine, Methyl Gluceth-20, Isononyl Isononanoate, Cyclopentasiloxane, Glycerin, Niacinamide, Hydrogenated Poly(C6-14 Olefin), Caprylic/Capric Triglyceride, Cyclohexasiloxane, Cetearyl Alcohol, Boswellia Serrata Extract, CentellaAsiatica Extract, Dioscorea Japonica Root Extract, Portulaca Oleracea Extract, Caprylyl Glycol, Dimethicone/Vinyl DimethiconeCrosspolymer, 1,2-Hexanediol, Sodium Polyacrylate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tocopheryl Acetate, Tromethamine, Carbomer, Sodium Hyaluronate, Dipotassium Glycyrrhizate, Ethylhexylglycerin, Adenosine, Hydrolyzed Corn Starch, XANTHAN GUM, Disodium EDTA, Trideceth-6, PEG/PPG-18/18 Dimethicone, Beta-Glucan, Sucrose, PEG-100 Stearate, Glyceryl Stearate, Cetearyl Glucoside, SorbitanOlivate, SorbitanSesquioleate, Polysorbate 60, Stearic Acid, Fragrance

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Problematic nails and skin improvement moisturizer


Advanced Ingredient Data


Raw Label Data

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