SPL v2
SPL
SPL Set ID a2b22fe6-822e-7c5c-e053-2995a90a7104
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
Water Glycerin Carbomer Homopolymer, Unspecified Type Urea Trolamine

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 reach of children.

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

3. Use with caution for those who are allergic to ethanol.

4. Intimate. Store away from light and store in a cool place. Dry. Hand wind.

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: Take an appropriate amount of this product to the palm of your hand, rub your hands together to evenly coat each part. Play for 1 minute.

2.Surgical hand disinfection: After surgical hand washing, take an appropriate amount of this product and evenly spread it on both

hands. The skin on the lower third of the forearm and upper arm. Take 3 to 5 minutes.

Dosage and Administration

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. Use with caution for those who are allergic to ethanol.

4. Keep tightly closed, protected from light, and store in a cool, dry and ventilated place.

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

Description

Proper amount

Section 43678-2

Proper amount

Section 50565-1

keep out of children

Section 51727-6

Purified Water

Glycerol

Urea

Carbomer

Triethanolamine

Section 51945-4

Section 55105-1

No need to use water for cleaning and disinfecting hands.

Section 55106-9

alcohol


Structured Label Content

Indications and Usage (34067-9)

1. Hygienic hand disinfection: Take an appropriate amount of this product to the palm of your hand, rub your hands together to evenly coat each part. Play for 1 minute.

2.Surgical hand disinfection: After surgical hand washing, take an appropriate amount of this product and evenly spread it on both

hands. The skin on the lower third of the forearm and upper arm. Take 3 to 5 minutes.

Dosage and Administration (34068-7)

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. Use with caution for those who are allergic to ethanol.

4. Keep tightly closed, protected from light, and store in a cool, dry and ventilated place.

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

Warnings and Precautions (34071-1)

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

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

3. Use with caution for those who are allergic to ethanol.

4. Intimate. Store away from light and store in a cool place. Dry. Hand wind.

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

Section 43678-2 (43678-2)

Proper amount

Section 50565-1 (50565-1)

keep out of children

Section 51727-6 (51727-6)

Purified Water

Glycerol

Urea

Carbomer

Triethanolamine

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

No need to use water for cleaning and disinfecting hands.

Section 55106-9 (55106-9)

alcohol


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)