SPL v2
SPL
SPL Set ID 46c30329-e8b8-a123-e063-6394a90a85be
Route
TOPICAL
Published
Effective Date 2025-12-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Isopropyl Alcohol (30 mL)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-25

Description

Isopropyl Alcohol, 70% v/v


Medication Information

Warnings and Precautions

For external use only. Flammable, keep away from fire or flame.

Indications and Usage

Directions

Wipe injection site vigorosly and discard.

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

Sterility guaranteed unless package is damaged or opened.

Not made with natural rubber latex.

Section 50565-1

If swallowed, get medical help or contact a poison control center right away.

Section 50566-9

Stop use and ask a doctor if irritation and redness develop.

Section 50570-1
  • With electrocautery procedures.
  • In the eyes. If contact occurs, flush eyes with water.

Section 51727-6

Purified Water

Section 51945-4

Section 55105-1

Antiseptic Cleanser.

Use for preparation of the skin prior to an injection.

Section 55106-9

Isopropyl Alcohol, 70% v/v

Section 60561-8

Store at room temperature


Structured Label Content

Indications and Usage (34067-9)

Directions

Wipe injection site vigorosly and discard.

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.

Description (34089-3)

Sterility guaranteed unless package is damaged or opened.

Not made with natural rubber latex.

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a poison control center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation and redness develop.

Section 50570-1 (50570-1)
  • With electrocautery procedures.
  • In the eyes. If contact occurs, flush eyes with water.

Section 51727-6 (51727-6)

Purified Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antiseptic Cleanser.

Use for preparation of the skin prior to an injection.

Section 55106-9 (55106-9)

Isopropyl Alcohol, 70% v/v

Section 60561-8 (60561-8)

Store at room temperature


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)