80138-202

80138-202
SPL v1
SPL
SPL Set ID ad9951f0-016f-28e9-e053-2995a90afa2f
Route
TOPICAL
Published
Effective Date 2020-08-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Butylene Glycol Trolamine Water Glycerin Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-08-25

Description

Alcohol 70%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Alcohol 70%

Use

Hand Sanitizer to help reduce bacteria on the skin. For use when soap and water are not available.

Warnings

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

Do not use

- on infants less 2months of age

- on open skin wounds

Directions

- Place 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.

Package Label

Active Ingredient

Alcohol 70%

Other Information

- Store between 1~30℃(33.8~86℉)

- Avoid freezing and excessive heat above 40℃(104℉)

Inactive Ingredients

glycerin, 1,3-butylene glycol, carbomer940, triethanol amine, purified water USP

When Using This Product

keep away from 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

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Use (USE)

Hand Sanitizer to help reduce bacteria on the skin. For use when soap and water are not available.

Purpose

Antiseptic

Warnings (WARNINGS)

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

Do not use

- on infants less 2months of age

- on open skin wounds

Directions (DIRECTIONS)

- Place 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.

Package Label

Active Ingredient (Active ingredient)

Alcohol 70%

Other Information (OTHER INFORMATION)

- Store between 1~30℃(33.8~86℉)

- Avoid freezing and excessive heat above 40℃(104℉)

Inactive Ingredients (INACTIVE INGREDIENTS)

glycerin, 1,3-butylene glycol, carbomer940, triethanol amine, purified water USP

When Using This Product (When using this product)

keep away from eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

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

if irritation or rash occurs. These may be 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

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