Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID d580e439-2710-74b2-e053-2995a90a513c
Route
TOPICAL
Published
Effective Date 2022-01-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Propanediol (2 g)
Inactive Ingredients
Water Allantoin

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2022-01-13

Description

PROPANEDIOL


Medication Information

Warnings and Precautions

1. In case of having side effects such as red rash, swollenness and/or itching while using this cosmetic, or in case such symptoms appear by direct sunlight after using it, consult a dermatologist immediately. 2. Do not apply it on the part where you have a scar, eczema or dermatitis. 3. Precautions for treatment and storage (1) Keep it out of the reach of children (2) Avoid the place where the direct sunlight is. 4. (1) Observe the prescribed usage and dosage (2) Do not use for children under three years of age (3) Do not use during pregnancy, and do not use around the vulva just before childbirth.

Indications and Usage

apply proper amount to the skin and gently massage

Dosage and Administration

for external use only

Description

PROPANEDIOL

Section 50565-1

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6

Water

Butylene Glycol

Dipropylene Glycol

1,2-Hexanediol

Hydroxyethylcellulose

Alcohol

Sodium Hyaluronate

Allantoin

Betaine

Streptococcus Thermophilus Ferment

Bifida Ferment Lysate

Lactobacillus Ferment Lysate

Hydrogenated Lecithin

Ceramide NP

Heptasodium Hexacarboxymethyl Dipeptide-12

Plantago Asiatica Extract

Angelica Archangelica Root Extract

Chamomilla Recutita (Matricaria) Extract

Sophora Angustifolia Root Extract

Artemisia Vulgaris Extract

Punica Granatum Fruit Extract

Leonurus Sibiricus Flower/Leaf/Stem Extract

Usnea Barbata (Lichen) Extract

Pulsatilla Koreana Extract

Zanthoxylum Piperitum Fruit Extract

Hydrogenated Polyisobutene

Anemarrhena Asphodeloides Root Extract

Panax Ginseng Callus Culture Extract

Sophora Japonica Callus Culture Extract

Oryza Sativa (Rice) Callus Culture Extract

Camellia Sinensis Callus Culture Extract

Menthol

Chlorphenesin

Citric Acid

Methylpropanediol

Caprylyl Glycol

Ethylhexylglycerin

Steareth-30

Chlorhexidine Digluconate

Disodium EDTA

Polyglyceryl-10 Laurate

Diethylhexyl Sodium Sulfosuccinate

Section 51945-4

Section 55105-1

1. Take off the plastic bag with a clean hands.

2. Apply it to your skin after remove a cap

Section 55106-9

PROPANEDIOL


Structured Label Content

Indications and Usage (34067-9)

apply proper amount to the skin and gently massage

Dosage and Administration (34068-7)

for external use only

Warnings and Precautions (34071-1)

1. In case of having side effects such as red rash, swollenness and/or itching while using this cosmetic, or in case such symptoms appear by direct sunlight after using it, consult a dermatologist immediately. 2. Do not apply it on the part where you have a scar, eczema or dermatitis. 3. Precautions for treatment and storage (1) Keep it out of the reach of children (2) Avoid the place where the direct sunlight is. 4. (1) Observe the prescribed usage and dosage (2) Do not use for children under three years of age (3) Do not use during pregnancy, and do not use around the vulva just before childbirth.

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6 (51727-6)

Water

Butylene Glycol

Dipropylene Glycol

1,2-Hexanediol

Hydroxyethylcellulose

Alcohol

Sodium Hyaluronate

Allantoin

Betaine

Streptococcus Thermophilus Ferment

Bifida Ferment Lysate

Lactobacillus Ferment Lysate

Hydrogenated Lecithin

Ceramide NP

Heptasodium Hexacarboxymethyl Dipeptide-12

Plantago Asiatica Extract

Angelica Archangelica Root Extract

Chamomilla Recutita (Matricaria) Extract

Sophora Angustifolia Root Extract

Artemisia Vulgaris Extract

Punica Granatum Fruit Extract

Leonurus Sibiricus Flower/Leaf/Stem Extract

Usnea Barbata (Lichen) Extract

Pulsatilla Koreana Extract

Zanthoxylum Piperitum Fruit Extract

Hydrogenated Polyisobutene

Anemarrhena Asphodeloides Root Extract

Panax Ginseng Callus Culture Extract

Sophora Japonica Callus Culture Extract

Oryza Sativa (Rice) Callus Culture Extract

Camellia Sinensis Callus Culture Extract

Menthol

Chlorphenesin

Citric Acid

Methylpropanediol

Caprylyl Glycol

Ethylhexylglycerin

Steareth-30

Chlorhexidine Digluconate

Disodium EDTA

Polyglyceryl-10 Laurate

Diethylhexyl Sodium Sulfosuccinate

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

1. Take off the plastic bag with a clean hands.

2. Apply it to your skin after remove a cap

Section 55106-9 (55106-9)

PROPANEDIOL


Advanced Ingredient Data


Raw Label Data

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