Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID d030a64f-e9c5-4c4b-8dd4-abed0f48700c
Route
TOPICAL
Published
Effective Date 2014-03-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Allantoin (0.0005 g)
Inactive Ingredients
Water Glycerin Cyclomethicone Propylene Glycol Arbutin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-03-15
Description

allantoin

Medication Information

Warnings and Precautions

1. if you have any abnormal symptoms as followings, you should discontinue to use this cream.  In case of using continuously, you have to consult to dermatologist because it may make symptoms worse.

a. red macule, swelling, urtication, and irritation during use

b. symptoms like above by direct ray

2. do not use if you have a wound, eczema, and dermatitis to the area where you apply this cream

3. caution during storing and handling

a. close the cap after use

b. keep it to the area where babies and infants cannot reachto

c. keep it to the area where has not high or low temperature and has no direct ray





Indications and Usage

after foundation, apply small amounts to whole face by tapping until it is absorbed to skin completely





Dosage and Administration

for external use only

Description

allantoin

Section 50565-1

keep out of reach of the children

Section 51727-6

water,  cyclomethicone, titanium dioxide, zinc oxide, ethylhexyl methoxycinnamate, panax ginseng root ext, peg-7 dimethicone, propylene glycol, arbutin, bentonite, cetyl peg/ppg-10/1 dimethicone, hexyl laurate, betaine, polymethyl methacrylate, sodium chloride, etc
Section 51945-4
Section 55105-1

whitening

anti-wrinkle

sun block



Section 55106-9

allantoin



Structured Label Content

Indications and Usage (34067-9)

after foundation, apply small amounts to whole face by tapping until it is absorbed to skin completely





Dosage and Administration (34068-7)

for external use only

Warnings and Precautions (34071-1)

1. if you have any abnormal symptoms as followings, you should discontinue to use this cream.  In case of using continuously, you have to consult to dermatologist because it may make symptoms worse.

a. red macule, swelling, urtication, and irritation during use

b. symptoms like above by direct ray

2. do not use if you have a wound, eczema, and dermatitis to the area where you apply this cream

3. caution during storing and handling

a. close the cap after use

b. keep it to the area where babies and infants cannot reachto

c. keep it to the area where has not high or low temperature and has no direct ray





Section 50565-1 (50565-1)

keep out of reach of the children

Section 51727-6 (51727-6)

water,  cyclomethicone, titanium dioxide, zinc oxide, ethylhexyl methoxycinnamate, panax ginseng root ext, peg-7 dimethicone, propylene glycol, arbutin, bentonite, cetyl peg/ppg-10/1 dimethicone, hexyl laurate, betaine, polymethyl methacrylate, sodium chloride, etc
Section 51945-4 (51945-4)
Section 55105-1 (55105-1)

whitening

anti-wrinkle

sun block



Section 55106-9 (55106-9)

allantoin



Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:46.331557 · Updated: 2026-03-14T22:53:42.713163