Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 2fda803a-debc-4350-8255-2357308bb927
Route
TOPICAL
Published
Effective Date 2015-05-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Allantoin (0.3 g)
Inactive Ingredients
Water Panthenol Niacinamide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2015-05-07

Description

allantoin


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 product if rash, irritation, itching and symptopms of hypersnesitivity occur dicontinue use and consult ypur 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

spray to the hair loss area of the scalp 1~2 times daily

gently message it throughout the hair loss area for optimal results

do not wash or rinse for at least two hours



Dosage and Administration

for external use only



Description

allantoin

Section 50565-1

keep out or reach of the children



Section 51727-6

water, alcohol, hydrolyzed silk, dimethyl isosorbide, grape seed ext, green tea ext, panthenol, benzyl alcohol, niacinamide, etc.

Section 51945-4
Section 55105-1

hair growth and loss prevention



Section 55106-9

allantoin




Structured Label Content

Indications and Usage (34067-9)

spray to the hair loss area of the scalp 1~2 times daily

gently message it throughout the hair loss area for optimal results

do not wash or rinse for at least two hours



Dosage and Administration (34068-7)

for external 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 product if rash, irritation, itching and symptopms of hypersnesitivity occur dicontinue use and consult ypur 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 or reach of the children



Section 51727-6 (51727-6)

water, alcohol, hydrolyzed silk, dimethyl isosorbide, grape seed ext, green tea ext, panthenol, benzyl alcohol, niacinamide, etc.

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

hair growth and loss prevention



Section 55106-9 (55106-9)

allantoin




Advanced Ingredient Data


Raw Label Data

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