Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 36986359-867e-49a7-bbdd-9101edd4366b
Route
TOPICAL
Published
Effective Date 2013-05-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Allantoin (0.02 mg)
Inactive Ingredients
Water Glycerin .alpha.-tocopherol Acetate Sodium Chloride Dimethicone Coconut Oil Aloe Vera Leaf Niacinamide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-05-27

Description

allantoin


Medication Information

Warnings and Precautions

1. If you experience following occasions after using this product, stop using. If your symptom got worse, have a consultation with dermatologist.

1) When you have problems such as red spots, swelling, itching, and stimulus

2) If applied parts have problems like above due to direct ray of light

2. Do not use for the parts with wound, eczema, and dermatitis.

3. Suggestions in regard of keeping and treatment

1) Make sure to close the stopper after using

2) Keep it in the place where infants or children's hands do not reach

3) Do not keep it in the place with high and low temperature and sunlight touches







Indications and Usage

Cover it on your whole face avoiding eyes after cleansing and make it absorbed softly.





Dosage and Administration

for topical use only



Description

allantoin

Section 50565-1

keep out of reach of the children



Section 51727-6

water, niacinamide, glycerine, butylene glycol, dimethicone, tocopheryl acetate, green tea extract, panthenol, aloe vera extract



Section 51945-4
Section 55105-1

skin protentants



Section 55106-9

allantoin




Structured Label Content

Indications and Usage (34067-9)

Cover it on your whole face avoiding eyes after cleansing and make it absorbed softly.





Dosage and Administration (34068-7)

for topical use only



Warnings and Precautions (34071-1)

1. If you experience following occasions after using this product, stop using. If your symptom got worse, have a consultation with dermatologist.

1) When you have problems such as red spots, swelling, itching, and stimulus

2) If applied parts have problems like above due to direct ray of light

2. Do not use for the parts with wound, eczema, and dermatitis.

3. Suggestions in regard of keeping and treatment

1) Make sure to close the stopper after using

2) Keep it in the place where infants or children's hands do not reach

3) Do not keep it in the place with high and low temperature and sunlight touches







Section 50565-1 (50565-1)

keep out of reach of the children



Section 51727-6 (51727-6)

water, niacinamide, glycerine, butylene glycol, dimethicone, tocopheryl acetate, green tea extract, panthenol, aloe vera extract



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

skin protentants



Section 55106-9 (55106-9)

allantoin




Advanced Ingredient Data


Raw Label Data

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