75427-013

75427-013
SPL v2
SPL
SPL Set ID ab7eeed2-8549-0f92-e053-2a95a90ad3cc
Route
topical
Published
Effective Date 2020-06-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (75 mL)
Inactive Ingredients
carbomer homopolymer type c (allyl pentaerythritol crosslinked) water propylene glycol glycerin trolamine

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-06-28

Purpose

Antiseptic

Description

Ethyl Alcohol 75%


Medication Information

Warnings

For External Use Only. Flammable. Keep Away From Heat Or Flame.

Uses

●Hand sanitizer to help reduce bacteria.

●For use when soap and water are not available

Purpose

Antiseptic

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

Other Information

Store between 59°-86°F (15°-30℃)

Do not store above 104°F (40℃)

Inactive Ingredients

Carbopol 940, Glycerine, Propylene GlycoL, Triethanolamine, Water (Aqua)

Description

Ethyl Alcohol 75%

Do Not Use

●on children less than 2 months of age.

●on open skin wounds.

Active Ingredient

Ethyl Alcohol 75%

When Using This Product

keep out of ears, eyes 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.

Package Label Principal Display Panel


Structured Label Content

Warnings (WARNINGS)

For External Use Only. Flammable. Keep Away From Heat Or Flame.

Uses

●Hand sanitizer to help reduce bacteria.

●For use when soap and water are not available

Purpose

Antiseptic

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

Other Information

Store between 59°-86°F (15°-30℃)

Do not store above 104°F (40℃)

Inactive Ingredients

Carbopol 940, Glycerine, Propylene GlycoL, Triethanolamine, Water (Aqua)

Do Not Use (Do not use)

●on children less than 2 months of age.

●on open skin wounds.

Active Ingredient (ACTIVE INGREDIENT)

Ethyl Alcohol 75%

When Using This Product (When using this product)

keep out of ears, eyes 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.

Package Label Principal Display Panel


Advanced Ingredient Data


Raw Label Data

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