SPL v1
SPL
SPL Set ID 963fa2d4-d99c-41b8-91b9-c0e0f0e77329
Route
TOPICAL
Published
Effective Date 2014-09-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Isopropyl Alcohol (0.14 g)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-08-22

Description

Active Ingredient: Isopropyl Alcohol (70%)


Medication Information

Warnings and Precautions

Warnings:

For external use only

Flammable. Keep away from fire or flame

Do not use:

With electrocautery procedures

In the eyes. If contact occurs, flush eyes with water.

Indications and Usage

Use:

For preparation of the skin prior to an injection

Dosage and Administration

Directions:

Wipe injection site vigorously and discard

Description

Active Ingredient: Isopropyl Alcohol (70%)

Section 44425-7

Other Information:

  • Store at room temperature
  • Avoid excessive heat (above 104F or 40C)
  • Protect from freezing
  • Latex free
Section 50565-1

Caution Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away

Section 50569-3

Stop use:

If irritation or redness develop

If condition persists consult your healthcare practitioner

Section 51727-6

Inactive Ingredient

Purified water

Section 51945-4

Section 55105-1

Purpose: Antiseptic

Section 55106-9

Active Ingredient: Isopropyl Alcohol (70%)


Structured Label Content

Indications and Usage (34067-9)

Use:

For preparation of the skin prior to an injection

Dosage and Administration (34068-7)

Directions:

Wipe injection site vigorously and discard

Warnings and Precautions (34071-1)

Warnings:

For external use only

Flammable. Keep away from fire or flame

Do not use:

With electrocautery procedures

In the eyes. If contact occurs, flush eyes with water.

Section 44425-7 (44425-7)

Other Information:

  • Store at room temperature
  • Avoid excessive heat (above 104F or 40C)
  • Protect from freezing
  • Latex free
Section 50565-1 (50565-1)

Caution Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away

Section 50569-3 (50569-3)

Stop use:

If irritation or redness develop

If condition persists consult your healthcare practitioner

Section 51727-6 (51727-6)

Inactive Ingredient

Purified water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose: Antiseptic

Section 55106-9 (55106-9)

Active Ingredient: Isopropyl Alcohol (70%)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)