SPL v1
SPL
SPL Set ID f7968dca-0e04-4d70-af41-63008e1fc8c1
Route
TOPICAL
Published
Effective Date 2020-06-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (42 mL)
Inactive Ingredients
Water Carbomer Homopolymer, Unspecified Type Glycerin Propylene Glycol Trolamine Polysorbate 80 Aloe Vera Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-06-01

Description

Ethyl alcohol 70%

Purpose

ANTISEPTIC


Medication Information

Purpose

ANTISEPTIC

Description

Ethyl alcohol 70%

Uses

• Hand sanitizer to help reduce bacteria that potentially can cause disease.

• Recommended for repeated use.

Warnings

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

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Do not use

• in children less than 2 months of age

• on open skin wounds

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

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Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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.

• Not recommended for infants

Active Ingredient

Ethyl alcohol 70%

Other Information

• Store between 1℃-30℃ (33.8℉-86℉)

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

Inactive Ingredients

Water, Carbomer, Glycerin, Propylene Glycol, Triethanolamine, Polysorbate 80, Aloe barbadensis leaf extract, Fragrance

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 that potentially can cause disease.

• Recommended for repeated use.

Purpose (PURPOSE)

ANTISEPTIC

Warnings (WARNINGS)

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

--------------------------------------------------------------------------------------------------------

Do not use

• in children less than 2 months of age

• on open skin wounds

--------------------------------------------------------------------------------------------------------

When using this product keep out of 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.

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.

• Not recommended for infants

Active Ingredient (ACTIVE INGREDIENT)

Ethyl alcohol 70%

Other Information

• Store between 1℃-30℃ (33.8℉-86℉)

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

Inactive Ingredients (INACTIVE INGREDIENTS)

Water, Carbomer, Glycerin, Propylene Glycol, Triethanolamine, Polysorbate 80, Aloe barbadensis leaf extract, Fragrance

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 (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)


Advanced Ingredient Data


Raw Label Data

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