SPL v1
SPL
SPL Set ID a5f7f7ad-cc2e-d41b-e053-2a95a90aa6d5
Route
TOPICAL
Published
Effective Date 2020-05-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (248 mL)
Inactive Ingredients
Glycerin Green Tea Leaf Artemisia Princeps Leaf Water Carbomer Homopolymer, Unspecified Type Levomenthol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-05-19

Description

ALCOHOL

Purpose

SANITIZER


Medication Information

Purpose

SANITIZER

Description

ALCOHOL

Uses

Disinfection of hands and skin

Warnings

1.Do not use the product on the following areas:

Around the eyes and ears, in the mouth, large body parts and damaged skin(Irritation may occur)

2.If you experience any of the following symptoms, discontinue use of the product immediately and consult a physician or pharmacist.



1) Hypersensitivity symptoms, e.g. rash, erythema, itchiness, and edema



2)Skin irritation symptoms

3.Other precautions



1) For external use only (do not swallow).



2) Avoid contact with eyes. If contact occurs, wash with clean water and consult a doctor or pharmacist.



3)Be careful not to inhale vapors in cases of extended or prolonged use. (Repeating inhaling of large amounts of ethanol vapor may cause irritation of the mucous membranes and headaches).

Directions

Take an appropriate amount on your hands and rub thoroughly to dry.

Active Ingredient

ALCOHOL

Inactive Ingredient

glycerin carbomer, green tea extract, aloe extract, mugwort extract, L-menthol, triethanolamine

Keep Out of Reach of Children

Keep out of reach of children and go to the hospital immediately if swallowed.

Package Label.principal Display Panel


Structured Label Content

Uses

Disinfection of hands and skin

Purpose (PURPOSE)

SANITIZER

Warnings (WARNINGS)

1.Do not use the product on the following areas:

Around the eyes and ears, in the mouth, large body parts and damaged skin(Irritation may occur)

2.If you experience any of the following symptoms, discontinue use of the product immediately and consult a physician or pharmacist.



1) Hypersensitivity symptoms, e.g. rash, erythema, itchiness, and edema



2)Skin irritation symptoms

3.Other precautions



1) For external use only (do not swallow).



2) Avoid contact with eyes. If contact occurs, wash with clean water and consult a doctor or pharmacist.



3)Be careful not to inhale vapors in cases of extended or prolonged use. (Repeating inhaling of large amounts of ethanol vapor may cause irritation of the mucous membranes and headaches).

Directions

Take an appropriate amount on your hands and rub thoroughly to dry.

Active Ingredient (ACTIVE INGREDIENT)

ALCOHOL

Inactive Ingredient (INACTIVE INGREDIENT)

glycerin carbomer, green tea extract, aloe extract, mugwort extract, L-menthol, triethanolamine

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

Keep out of reach of children and go to the hospital immediately if swallowed.

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)


Advanced Ingredient Data


Raw Label Data

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