SPL v1
SPL
SPL Set ID 36a5c0da-3806-4ecf-97cd-93566c91d0dd
Route
TOPICAL
Published
Effective Date 2020-05-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (350 mL)
Inactive Ingredients
Water Aloe Vera Leaf Glycerin Carbomer Homopolymer, Unspecified Type Butylene Glycol Lemon Trolamine 1,2-hexanediol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-05-01

Description

ALCOHOL 70% v/v

Purpose

ANTISEPTIC


Medication Information

Purpose

ANTISEPTIC

Description

ALCOHOL 70% v/v

Uses

Hand sanitizer to help reduce bacteria on the skin

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 in your palm to cover hands. Rub hands together until dry.

• Children under 6 years of age should be supervised when using the product

Active Ingredient

ALCOHOL 70% v/v

Other Information

• Store between 15-30C (59-86F)

• Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients

Water, Aloe Barbadensis Leaf Extract, Glycerin, Carbomer, Butylene Glycol, Citrus Limon Fruit Extract, Triethanolamine, 1,2-Hexanediol

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 on the skin

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 in your palm to cover hands. Rub hands together until dry.

• Children under 6 years of age should be supervised when using the product

Active Ingredient (ACTIVE INGREDIENT)

ALCOHOL 70% v/v

Other Information (Other information)

• Store between 15-30C (59-86F)

• Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients (INACTIVE INGREDIENTS)

Water, Aloe Barbadensis Leaf Extract, Glycerin, Carbomer, Butylene Glycol, Citrus Limon Fruit Extract, Triethanolamine, 1,2-Hexanediol

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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