SPL v2
SPL
SPL Set ID a2b12248-fba1-d840-e053-2a95a90a8992
Route
EXTRACORPOREAL
Published
Effective Date 2020-04-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (375 mL)
Inactive Ingredients
Glycerin Urea Water

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-04-07

Description

Proper amount


Medication Information

Warnings and Precautions

1. This product is a disinfectant for external use and should not be taken orally. Keep out of the reach of children.

2. This product is flammable and should be kept away from fire.

3. For those who are allergic to ethanol.

4. Keep in air, keep away from light and store in a cool, dry and ventilated place.

5. This product contains ethanol and is volatile. Please use as soon as possible after opening the bottle.

Indications and Usage

1. Hygienic hand disinfection: Mist or rub the original liquid evenly on the palm of the hand. Rub your hands together to evenly coat each part for 1 minute.

2.Surgical hand disinfection: After washing hands, take appropriate amount of the original liquid and apply it to the skin of the hands, forearm and upper 1/3 of the lower arm. Act for 3 ~ 5 minutes.

Dosage and Administration

Proper amount

Description

Proper amount

Section 50565-1

keep out of reach of cildren section

Section 51727-6

Glycerine

Urea

Purified water

Section 51945-4

Section 55105-1

Make hands clean quickly

Section 55106-9

alcohol


Structured Label Content

Indications and Usage (34067-9)

1. Hygienic hand disinfection: Mist or rub the original liquid evenly on the palm of the hand. Rub your hands together to evenly coat each part for 1 minute.

2.Surgical hand disinfection: After washing hands, take appropriate amount of the original liquid and apply it to the skin of the hands, forearm and upper 1/3 of the lower arm. Act for 3 ~ 5 minutes.

Dosage and Administration (34068-7)

Proper amount

Warnings and Precautions (34071-1)

1. This product is a disinfectant for external use and should not be taken orally. Keep out of the reach of children.

2. This product is flammable and should be kept away from fire.

3. For those who are allergic to ethanol.

4. Keep in air, keep away from light and store in a cool, dry and ventilated place.

5. This product contains ethanol and is volatile. Please use as soon as possible after opening the bottle.

Section 50565-1 (50565-1)

keep out of reach of cildren section

Section 51727-6 (51727-6)

Glycerine

Urea

Purified water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Make hands clean quickly

Section 55106-9 (55106-9)

alcohol


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)