Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID a79098e1-bdaf-6653-e053-2995a90a6f11
Route
TOPICAL
Published
Effective Date 2020-06-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 mL)
Inactive Ingredients
Peg-60 Hydrogenated Castor Oil Water Carbomer 940 Trolamine Butylene Glycol 1,2-hexanediol Glycerin .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-06-06

Description

Alcohol


Medication Information

Warnings and Precautions

1. Do not use this product on the following parts of body. Around eyes and ears, oral cavity, large area of the

parts of body, or wounded skins (It may cause irritations)

2. Stop using at once in case of the following symptoms, and seek medical advice. 1) When eczema, red spots,

itchiness, edema, and allergic reactions occur. 2)When skin irritations happen.

3. Other user reminders 1) For external use only(No oral intake). 2) Avoid contact with eyes, and in case contact

occurs, rinse it thoroughly with clean water and consult a doctor or pharmacist. 3) When you use it on a large skin

area or use it long-termly, please be aware that vapor is not absorbed. (If Ethanol vapor is largely and repeatedly

inhaled and absorbed, it may cause irritation to mucous membrane and headache might occur.) 4)When the product

is used on the same part of skin repeatedly, the skin may become rough due to skimming. 5) Do not use with sealed

gauze bandage, Gibbs bandage or pack, as irritations may occur. 6) Do not use this product while anus and vagina

steaming as irritations or chemical burns may occur. 7) Do not use for purposes other than specified.

Indications and Usage

Just apply it, let it dry a few seconds. No water or towels needed.

Dosage and Administration

external use only

Description

Alcohol

Section 50565-1

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6

Water

Glycerin

PEG-60 Hydrogenated Castor Oil

Carbomer

Triethanolamine

Fragrance

Citrus Aurantium Dulcis (Orange) Fruit Extract

Citrus Paradisi (Grapefruit) Fruit Extract

Citrus Tangerina (Tangerine) Extract

Sodium Hyaluronate

Tocopherol

Butylene Glycol

1,2-Hexanediol

Section 51945-4

Section 55105-1

Instantly kils most common germs and bacteria without damaging skin and stop some viruses.

Great alternative when soap and water are not available.

Disposable and quick-drying.

Perfect and convenient to carry in purse, school backpacks and travel bags.

Section 55106-9

Alcohol


Structured Label Content

Indications and Usage (34067-9)

Just apply it, let it dry a few seconds. No water or towels needed.

Dosage and Administration (34068-7)

external use only

Warnings and Precautions (34071-1)

1. Do not use this product on the following parts of body. Around eyes and ears, oral cavity, large area of the

parts of body, or wounded skins (It may cause irritations)

2. Stop using at once in case of the following symptoms, and seek medical advice. 1) When eczema, red spots,

itchiness, edema, and allergic reactions occur. 2)When skin irritations happen.

3. Other user reminders 1) For external use only(No oral intake). 2) Avoid contact with eyes, and in case contact

occurs, rinse it thoroughly with clean water and consult a doctor or pharmacist. 3) When you use it on a large skin

area or use it long-termly, please be aware that vapor is not absorbed. (If Ethanol vapor is largely and repeatedly

inhaled and absorbed, it may cause irritation to mucous membrane and headache might occur.) 4)When the product

is used on the same part of skin repeatedly, the skin may become rough due to skimming. 5) Do not use with sealed

gauze bandage, Gibbs bandage or pack, as irritations may occur. 6) Do not use this product while anus and vagina

steaming as irritations or chemical burns may occur. 7) Do not use for purposes other than specified.

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6 (51727-6)

Water

Glycerin

PEG-60 Hydrogenated Castor Oil

Carbomer

Triethanolamine

Fragrance

Citrus Aurantium Dulcis (Orange) Fruit Extract

Citrus Paradisi (Grapefruit) Fruit Extract

Citrus Tangerina (Tangerine) Extract

Sodium Hyaluronate

Tocopherol

Butylene Glycol

1,2-Hexanediol

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Instantly kils most common germs and bacteria without damaging skin and stop some viruses.

Great alternative when soap and water are not available.

Disposable and quick-drying.

Perfect and convenient to carry in purse, school backpacks and travel bags.

Section 55106-9 (55106-9)

Alcohol


Advanced Ingredient Data


Raw Label Data

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