36a5c0da-3806-4ecf-97cd-93566c91d0dd

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

Purpose

ANTISEPTIC

Description

ALCOHOL 70% v/v


Medication Information

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.

Uses

Hand sanitizer to help reduce bacteria on the skin

Purpose

ANTISEPTIC

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

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

Description

ALCOHOL 70% v/v

Active Ingredient

ALCOHOL 70% v/v

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

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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.

Uses

Hand sanitizer to help reduce bacteria on the skin

Purpose (PURPOSE)

ANTISEPTIC

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

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

Active Ingredient (ACTIVE INGREDIENT)

ALCOHOL 70% v/v

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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