SPL v1
SPL
SPL Set ID 3c18d598-4bff-4c55-8abf-677ad2016df6
Route
TOPICAL
Published
Effective Date 2020-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (0.93 g)
Inactive Ingredients
Water Glycerin Carbomer Homopolymer, Unspecified Type Propylene Glycol Trolamine Menthol Green Tea Leaf Grapefruit Dimethicone .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2020-05-01

Description

ALCOHOL 62%

Purpose

SANITIZER


Medication Information

Purpose

SANITIZER

Description

ALCOHOL 62%

Uses

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

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.

Active Ingredient

ALCOHOL 62%

Other Information

• Store between 15-30℃ (59-86F)

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

Inactive Ingredients

Water, Glycerin, Carbomer, Propylene Glycol, Triethanolamine, Menthol, Camellia Sinensis Leaf Extract, Citrus Paradisi (Grapefruit) Fruit Extract,

Dimethicone, Tocopheryl Acetate, CI 42053

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.

Purpose (PURPOSE)

SANITIZER

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.

Active Ingredient (ACTIVE INGREDIENT)

ALCOHOL 62%

Other Information (Other information)

• Store between 15-30℃ (59-86F)

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

Inactive Ingredients (INACTIVE INGREDIENTS)

Water, Glycerin, Carbomer, Propylene Glycol, Triethanolamine, Menthol, Camellia Sinensis Leaf Extract, Citrus Paradisi (Grapefruit) Fruit Extract,

Dimethicone, Tocopheryl Acetate, CI 42053

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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