SPL v1
SPL
SPL Set ID 35ab90e2-bc8f-472b-8bd2-201aac059f02
Route
TOPICAL
Published
Effective Date 2020-09-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (350 mL)
Inactive Ingredients
Acorus Calamus Root Green Tea Leaf Carbomer Homopolymer, Unspecified Type Grapefruit Cnidium Officinale Root Beach Strawberry Glycyrrhiza Uralensis Root Lavender Oil Morus Alba Bark Sophora Flavescens Root Edetol .alpha.-tocopherol Acetate Water

Identifiers & Packaging

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

Description

Alcohol 70% v/v

Purpose

Hand Sanitizer


Medication Information

Purpose

Hand Sanitizer

Description

Alcohol 70% v/v

Uses

Can be used anytime and has effective Sterilization

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 70% v/v

Other Information

• Store between 15-30C (59-86F)

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

* Keep out of direct light and store in a cool, dry area

Inactive Ingredients

Acorus Calamus Root Extract, Camellia Sinensis Leaf Extract, Carbomer, Citrus Paradisi (Grapefruit) Fruit Extract, Cnidium Officinale Rhizome Extract, Fragaria Chiloensis (Strawberry) Fruit Extract, Glycyrrhiza Uralensis (Licorice) Root Extract, Lavandula Angustifolia (Lavender) Oil, Morus Alba Bark Extract, Sophora Angustifolia Root Extract, Tetrahydroxypropyl Ethylenediamine, Tocopheryl Acetate, 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

Can be used anytime and has effective Sterilization

Purpose (PURPOSE)

Hand 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

• 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 70% v/v

Other Information

• Store between 15-30C (59-86F)

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

* Keep out of direct light and store in a cool, dry area

Inactive Ingredients (INACTIVE INGREDIENTS)

Acorus Calamus Root Extract, Camellia Sinensis Leaf Extract, Carbomer, Citrus Paradisi (Grapefruit) Fruit Extract, Cnidium Officinale Rhizome Extract, Fragaria Chiloensis (Strawberry) Fruit Extract, Glycyrrhiza Uralensis (Licorice) Root Extract, Lavandula Angustifolia (Lavender) Oil, Morus Alba Bark Extract, Sophora Angustifolia Root Extract, Tetrahydroxypropyl Ethylenediamine, Tocopheryl Acetate, 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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