SPL v1
SPL
SPL Set ID a4013d63-8f46-60a0-e053-2a95a90a28c4
Route
EXTRACORPOREAL
Published
Effective Date 2020-04-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (395 mL)
Inactive Ingredients
Water

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-04-23

Description

Sealed and stored in a cool, ventilated and dry place.


Medication Information

Warnings and Precautions

1. This product is a topical disinfectant and should not be taken orall Keep out of reach of children.

2. Flammable, keep away from fire.

3. Use with caution to those who are allergic to alcohol.

4. Sealed and stored in a cool, ventilated and dry place.

Indications and Usage

Spray or rub this product evenly on the skin surface for 1 minute.

Disinfect the surface of the object: Spray or rub the product evenly on the surface of the object for 3 minutes.

Dosage and Administration

Sealed and stored in a cool, ventilated and dry place.

Description

Sealed and stored in a cool, ventilated and dry place.

Section 50565-1

keep out of children

Section 51727-6

purified water

Section 51945-4

Section 55105-1

Disinfection

Sterilization

Section 55106-9

ethyl alcohol


Structured Label Content

Indications and Usage (34067-9)

Spray or rub this product evenly on the skin surface for 1 minute.

Disinfect the surface of the object: Spray or rub the product evenly on the surface of the object for 3 minutes.

Dosage and Administration (34068-7)

Sealed and stored in a cool, ventilated and dry place.

Warnings and Precautions (34071-1)

1. This product is a topical disinfectant and should not be taken orall Keep out of reach of children.

2. Flammable, keep away from fire.

3. Use with caution to those who are allergic to alcohol.

4. Sealed and stored in a cool, ventilated and dry place.

Section 50565-1 (50565-1)

keep out of children

Section 51727-6 (51727-6)

purified water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Disinfection

Sterilization

Section 55106-9 (55106-9)

ethyl alcohol


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)