SPL v1
SPL
SPL Set ID bce9581d-72ee-4626-a595-006349c7320c
Route
TOPICAL
Published
Effective Date 2020-05-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Glycerin Hydrogen Peroxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-05-04

Description

Ethyl Alcohol 70% v/v.

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 70% v/v.

Uses

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Center right away.

Warnings

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

Do not use

- In 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 to cover all surfaces, rub hand together until dry, Supervise children under 6 years of age when using this product

to avoid swallowing.

Other information

Store between 15-30C (59-86F).

Avoid Freezing and excessive heat above 40C (104F)

Product Labels

Active Ingredient

Ethyl Alcohol 70% v/v.

Inactive Ingredients

Glycerin, Hydrogen Peroxide, Purified Water USP


Structured Label Content

Uses

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Center right away.

Purpose

Antiseptic

Warnings

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

Do not use

- In 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 to cover all surfaces, rub hand together until dry, Supervise children under 6 years of age when using this product

to avoid swallowing.

Other information

Store between 15-30C (59-86F).

Avoid Freezing and excessive heat above 40C (104F)

Product Labels

Active Ingredient

Ethyl Alcohol 70% v/v.

Inactive Ingredients (Inactive ingredients)

Glycerin, Hydrogen Peroxide, Purified Water USP


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)