Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID a99a0dca-9037-4d1b-e053-2995a90aff5b
Route
TOPICAL
Published
Effective Date 2020-07-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Peg-60 Hydrogenated Castor Oil Water Carbomer 934 Trolamine Chlorphenesin Butylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-07-04

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

Pump an appropriate amount on to the hands and rub together until dry

Dosage and Administration

external use only

Description

Alcohol

Section 50565-1

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6

Water, Carbomer, Triethanolamine, PEG-60 Hydrogenated Castor Oil, Fragrance, Chlorphenesin, Trideceth-10, Butylene Glycol, Origanum Vulgare Leaf Extract, Chamaecyparis Obtusa Leaf Extract, Salix Alba (Willow) Bark Extract, Cinnamomum Cassia Bark Extract, Lactobacillus/Soybean Ferment Extract, Portulaca Oleracea Extract, Vincetoxicum Atratum Extract, Scutellaria Baicalensis Root Extract, 1,2-Hexanediol, Caprylyl Glycol, Aloe Barbadensis Leaf Extract, Illicium Verum (Anise) Fruit Extract

Section 51945-4

Section 55105-1

■ instant healthcare personnel hand antiseptic to reduce bacteria that potentially can cause disease

■ instant hand antiseptic to decrease bacteria on the skin

Section 55106-9

Alcohol


Structured Label Content

Indications and Usage (34067-9)

Pump an appropriate amount on to the hands and rub together until dry

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, Carbomer, Triethanolamine, PEG-60 Hydrogenated Castor Oil, Fragrance, Chlorphenesin, Trideceth-10, Butylene Glycol, Origanum Vulgare Leaf Extract, Chamaecyparis Obtusa Leaf Extract, Salix Alba (Willow) Bark Extract, Cinnamomum Cassia Bark Extract, Lactobacillus/Soybean Ferment Extract, Portulaca Oleracea Extract, Vincetoxicum Atratum Extract, Scutellaria Baicalensis Root Extract, 1,2-Hexanediol, Caprylyl Glycol, Aloe Barbadensis Leaf Extract, Illicium Verum (Anise) Fruit Extract

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

■ instant healthcare personnel hand antiseptic to reduce bacteria that potentially can cause disease

■ instant hand antiseptic to decrease bacteria on the skin

Section 55106-9 (55106-9)

Alcohol


Advanced Ingredient Data


Raw Label Data

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