SPL v1
SPL
SPL Set ID 29269551-5610-2c5c-e063-6294a90a8a7e
Route
TOPICAL
Published
Effective Date 2024-09-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Isopropyl Alcohol (70 mL)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-01

Description

Isopropyl Alcohol 70% v/v


Medication Information

Warnings and Precautions

For external use only.

Flammable, keep away from fire or flame.



Do not use

with electrocautery procedures

in the eyes

on mucous membranes

on irritated skin.

Stop use and ask a doctor if irritation or redness develops.



Keep out of reach of children.



If swallowed, get medical help or contact a Poison Control center right away.

Indications and Usage

Use for preparation of skin prior to injection,apply the product to the skin, take the injection or puncturesite as the center, slowly rotate from the inside to the outside, and gradually apply the product for twotimes, the disinfection area should be more than 5cmx5cm, and the action time should be1min.Please clean before disinfection.

Dosage and Administration

Apply topically as needed to cleanse intendend area;

Apply the product to the skin, take the injection or puncture site as the center, slowly rotate from the insideto the outside, and gradually apply the product for two times, the disinfection area should be more than5cmx5cm, and the action time should be 1min.

Description

Use for preparation of skin prior to injection

Section 50565-1

keep out of reach of children.

Section 50570-1

Do not use the product when packaging is damaged.

Section 51727-6

Purified Water

Section 51945-4

Section 55105-1

Use for preparation of skin prior to injection, to clean the skin.

Section 55106-9

Isopropyl Alcohol 70% v/v

Section 60561-8

Store at room temperature 15 - 30°C (59 - 86°F)


Structured Label Content

Indications and Usage (34067-9)

Use for preparation of skin prior to injection,apply the product to the skin, take the injection or puncturesite as the center, slowly rotate from the inside to the outside, and gradually apply the product for twotimes, the disinfection area should be more than 5cmx5cm, and the action time should be1min.Please clean before disinfection.

Dosage and Administration (34068-7)

Apply topically as needed to cleanse intendend area;

Apply the product to the skin, take the injection or puncture site as the center, slowly rotate from the insideto the outside, and gradually apply the product for two times, the disinfection area should be more than5cmx5cm, and the action time should be 1min.

Warnings and Precautions (34071-1)

For external use only.

Flammable, keep away from fire or flame.



Do not use

with electrocautery procedures

in the eyes

on mucous membranes

on irritated skin.

Stop use and ask a doctor if irritation or redness develops.



Keep out of reach of children.



If swallowed, get medical help or contact a Poison Control center right away.

Description (34089-3)

Use for preparation of skin prior to injection

Section 50565-1 (50565-1)

keep out of reach of children.

Section 50570-1 (50570-1)

Do not use the product when packaging is damaged.

Section 51727-6 (51727-6)

Purified Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Use for preparation of skin prior to injection, to clean the skin.

Section 55106-9 (55106-9)

Isopropyl Alcohol 70% v/v

Section 60561-8 (60561-8)

Store at room temperature 15 - 30°C (59 - 86°F)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)