Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID db09bce4-f524-4e75-8c21-ae819eb5514e
Route
TOPICAL
Published
Effective Date 2015-02-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Allantoin (0.2 g)
Inactive Ingredients
Water Butylene Glycol Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-12-01

Description

allantoin


Medication Information

Warnings and Precautions

・Stop using the product when you have skin problems or the product disagrees with your skin

・Stop using the product immediately and consult a dermatologist if you have redness, swelling, itching or irritation on the skin while or after using the product.

・Don't place the product in any place where it will be subjected to extremely high or low temperatures or direct sunlight.



Indications and Usage

apply to the skin and rub gently



Dosage and Administration

for external use only

Description

allantoin

Section 50565-1

keep out of reach of the children

Section 51727-6

water, butylene glycol, glycerin, xanthan gum, etc



Section 51945-4
Section 55105-1

skin protectant

antioxidant



Section 55106-9

allantoin




Structured Label Content

Indications and Usage (34067-9)

apply to the skin and rub gently



Dosage and Administration (34068-7)

for external use only

Warnings and Precautions (34071-1)

・Stop using the product when you have skin problems or the product disagrees with your skin

・Stop using the product immediately and consult a dermatologist if you have redness, swelling, itching or irritation on the skin while or after using the product.

・Don't place the product in any place where it will be subjected to extremely high or low temperatures or direct sunlight.



Section 50565-1 (50565-1)

keep out of reach of the children

Section 51727-6 (51727-6)

water, butylene glycol, glycerin, xanthan gum, etc



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

skin protectant

antioxidant



Section 55106-9 (55106-9)

allantoin




Advanced Ingredient Data


Raw Label Data

All Sections (JSON)