75427-001

75427-001
SPL v2
SPL
SPL Set ID a7b5aad2-3e4a-e1f1-e053-2995a90a0371
Route
TOPICAL
Published
Effective Date 2020-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 mL)
Inactive Ingredients
Trolamine Carbomer 940 Propylene Glycol Glycerin Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-03-30

Description

Ethyl Alcohol 75%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 75%

Use

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

Section 50565-1

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

Section 50566-9

if iritation or rash occurs. These may be signs of a serious condition.

Section 50567-7

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

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

Other Information

●Store between 59°-86°F (15°-30℃)

●Do not store above 104°F (40℃)

Active Ingredient(s)

Ethyl Alcohol 75%

Inactive Ingredients

●Water (Aqua), Propylene Glycol, Glycerine, Carbopol 940, Triethanolamine

Package Label Principal Display Panel


Structured Label Content

Use

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)

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

Section 50566-9 (50566-9)

if iritation or rash occurs. These may be signs of a serious condition.

Section 50567-7 (50567-7)

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

Purpose

Antiseptic

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

Other Information (Other information)

●Store between 59°-86°F (15°-30℃)

●Do not store above 104°F (40℃)

Active Ingredient(s)

Ethyl Alcohol 75%

Inactive Ingredients (Inactive ingredients)

●Water (Aqua), Propylene Glycol, Glycerine, Carbopol 940, Triethanolamine

Package Label Principal Display Panel (Package Label - Principal Display Panel)


Advanced Ingredient Data


Raw Label Data

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