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

Description

Ethyl Alcohol 75%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 75%

Uses

●Hand sanitizer to help reduce bacteria.

●For use when soap and water are not available

Warnings

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

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

Do Not Use

●on children less than 2 months of age.

●on open skin wounds.

Active Ingredient

Ethyl Alcohol 75%

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)

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

Uses

●Hand sanitizer to help reduce bacteria.

●For use when soap and water are not available

Purpose

Antiseptic

Warnings (WARNINGS)

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

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

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%

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)

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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