Drug Facts

Composition & Product

Active Ingredients

Glycerin (8 g)

Inactive Ingredients

Water Shea Butter

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2019-01-04

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 to the skin and gently rub it to absorb it

Dosage and Administration

for topical use only

Description

glycerin

Section 50565-1

keep out of reach of the children

Section 51727-6

Water, Bentonite, SparassisCrispa Extract, Mineral oil, Cetearyl Alcohol, ButyrospermumParkii (Shea) Butter, Theobroma Cacao (Cocoa) Seed Butter, Hydrogenated Polyisobutene, CetylEthylhexanoate, Stearyl alcohol, Beeswax, Cocos Nucifera (Coconut) Oil, Cyclopentasiloxane, 1,2-Hexanediol, Olea Europaea (Olive) Fruit Oil, Cyclohexasiloxane, Cetearyl Glucoside, Dimethicone/Vinyl DimethiconeCrosspolymer, Dimethicone, Glyceryl Stearate, Disodium EDTA

Section 51945-4

Section 55105-1

for skin protectant

Section 55106-9

glycerin

Structured Label Content

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

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, Bentonite, SparassisCrispa Extract, Mineral oil, Cetearyl Alcohol, ButyrospermumParkii (Shea) Butter, Theobroma Cacao (Cocoa) Seed Butter, Hydrogenated Polyisobutene, CetylEthylhexanoate, Stearyl alcohol, Beeswax, Cocos Nucifera (Coconut) Oil, Cyclopentasiloxane, 1,2-Hexanediol, Olea Europaea (Olive) Fruit Oil, Cyclohexasiloxane, Cetearyl Glucoside, Dimethicone/Vinyl DimethiconeCrosspolymer, Dimethicone, Glyceryl Stearate, Disodium EDTA

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

for skin protectant

Section 55106-9 (55106-9)

glycerin

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SHEA BUTTER", "unii": "K49155WL9Y", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "ACTIB", "strengthNumerator": "8", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Apply to the skin and gently rub it to absorb it", "34068-7": "for topical use only", "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", "50565-1": "keep out of reach of the children", "51727-6": "Water, Bentonite, SparassisCrispa Extract, Mineral oil, Cetearyl Alcohol, ButyrospermumParkii (Shea) Butter, Theobroma Cacao (Cocoa) Seed Butter, Hydrogenated Polyisobutene, CetylEthylhexanoate, Stearyl alcohol, Beeswax, Cocos Nucifera (Coconut) Oil, Cyclopentasiloxane, 1,2-Hexanediol, Olea Europaea (Olive) Fruit Oil, Cyclohexasiloxane, Cetearyl Glucoside, Dimethicone/Vinyl DimethiconeCrosspolymer, Dimethicone, Glyceryl Stearate, Disodium EDTA", "55105-1": "for skin protectant", "55106-9": "glycerin"}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information