Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID bcd68601-d56d-4d94-89f8-0d18be6288d7
Route
TOPICAL
Published
Effective Date 2021-03-08
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 NOT FINAL Active Since 2021-02-25

Description

Isopropyl alcohol 70%, USP

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Isopropyl alcohol 70%, USP

Uses

Antiseptic and Hand Sanitizer to help reduce bacteria that may cause disease. For use when soap & water are unavailable.

Warnings

For external use only. Flammable. Keep away from heat or flame.

Do not use

on children less than 2 months of age

• on open skin wounds

When using this product keep out of eyes, ears, and mouth. In

case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may

be signs of a serious condition.

Directions

• Place enough product on hands or affected area to cover all surfaces. Rub hands together until dry.

• Supervise children under 6 years of age when using this product to avoid swallowing.

Product Label

Active Ingredient

Isopropyl alcohol 70%, USP

Other Information

Store between 15 °C and 30 °C. Avoid freezing and excessive heat above 400 °C (104 °F)

Inactive Ingredient

Water

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.


Structured Label Content

Uses

Antiseptic and Hand Sanitizer to help reduce bacteria that may cause disease. For use when soap & water are unavailable.

Purpose

Antiseptic

Warnings

For external use only. Flammable. Keep away from heat or flame.

Do not use

on children less than 2 months of age

• on open skin wounds

When using this product keep out of eyes, ears, and mouth. In

case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may

be signs of a serious condition.

Directions

• Place enough product on hands or affected area to cover all surfaces. Rub hands together until dry.

• Supervise children under 6 years of age when using this product to avoid swallowing.

Product Label (Product label)

Active Ingredient (Active ingredient)

Isopropyl alcohol 70%, USP

Other Information (Other information)

Store between 15 °C and 30 °C. Avoid freezing and excessive heat above 400 °C (104 °F)

Inactive Ingredient (Inactive ingredient)

Water

Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.


Advanced Ingredient Data


Raw Label Data

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