SPL v1
SPL
SPL Set ID b000150f-3beb-2e6c-e053-2995a90a67d5
Route
TOPICAL
Published
Effective Date 2020-09-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Water Hypromellose 2208 (60000 Mpa.s) Glycerin Carboxymethylcellulose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-09-23

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

Warnings

For external use only . flammable - keep away from heat or flame

Directions

Put enough product on hands to cover all surfaces. Rub hands together until dry.

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

Do Not Use

In children less than 2 months of age - on open skin wounds

Other Information

Store between 15-30C (58-86F)

Avoid freezing and excesive heat above 40C (104F)

Principal Display

Hand sanitizer

70% alcohol

68 fl. oz. (2.1qt) (2L)

Active Ingredients

Ethyl alcohol 70% v/v

Inactive Ingredients

Water (aqua), Vegetable Glycerine UPC, Hudroxypropyl methylcellulose and carboxymethylcellulose.

When Using This Product

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes throrugly with water

Stop Use and Ask A Doctor

if irritation or rash occurs. These maybe signs of a serious condition.

Keep Out of Reach of Children

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


Structured Label Content

Uses

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

Purpose

Antiseptic

Warnings

For external use only . flammable - keep away from heat or flame

Directions

Put enough product on hands to cover all surfaces. Rub hands together until dry.

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

Do Not Use (Do not use)

In children less than 2 months of age - on open skin wounds

Other Information (Other information)

Store between 15-30C (58-86F)

Avoid freezing and excesive heat above 40C (104F)

Principal Display

Hand sanitizer

70% alcohol

68 fl. oz. (2.1qt) (2L)

Active Ingredients

Ethyl alcohol 70% v/v

Inactive Ingredients (Inactive ingredients)

Water (aqua), Vegetable Glycerine UPC, Hudroxypropyl methylcellulose and carboxymethylcellulose.

When Using This Product (When using this product)

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes throrugly with water

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if irritation or rash occurs. These maybe signs of a serious condition.

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.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)