SPL v1
SPL
SPL Set ID 8b1bf2e6-bcc6-4cc5-9fcb-72cb0d333451
Route
TOPICAL
Published
Effective Date 2020-09-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (310 mL)
Inactive Ingredients
Aloe Butylene Glycol Carbomer Homopolymer, Unspecified Type Panthenol Trolamine Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-09-01

Description

Alcohol 62% v/v

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Alcohol 62% v/v

Uses

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

• For use when soap and water are not available.

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

• Apply to clean, dry hands. Apply sufficient amount to thoroughly wet all surfaces of hands and fingers. Rub onto hands until dry.

• Supervise children in the use of this product.

Active Ingredient

Alcohol 62% v/v

Other Information

• Store between 59-86℉ (15-30℃)

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

Inactive Ingredients

Aloe Extract, Butylene Glycol, CARBOMER, DL-Panthenol, Polyoxyethylene Hydrogenetated Caster Oil, Triethanolamine, Water

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


Structured Label Content

Uses

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

• For use when soap and water are not available.

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

• Apply to clean, dry hands. Apply sufficient amount to thoroughly wet all surfaces of hands and fingers. Rub onto hands until dry.

• Supervise children in the use of this product.

Active Ingredient (ACTIVE INGREDIENT)

Alcohol 62% v/v

Other Information (Other information)

• Store between 59-86℉ (15-30℃)

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

Inactive Ingredients (INACTIVE INGREDIENTS)

Aloe Extract, Butylene Glycol, CARBOMER, DL-Panthenol, Polyoxyethylene Hydrogenetated Caster Oil, Triethanolamine, Water

Keep Out of Reach of Children (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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