SPL v1
SPL
SPL Set ID c724be20-fe28-4823-a86a-867e670a0d7e
Route
TOPICAL
Published
Effective Date 2020-06-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (350 mL)
Inactive Ingredients
Water Glycerin Rosemary Green Tea Leaf Lavender Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-06-01

Description

ALCOHOL 70% v/v

Purpose

ANTISEPTIC


Medication Information

Purpose

ANTISEPTIC

Description

ALCOHOL 70% v/v

Uses

• instant hand antiseptic to 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

• 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)

Inactive Ingredient

Water, Glycerin, Flavor, Rosmarinus Officinalis (Rosemary) Extract, Camellia Sinensis Leaf Extract, Lavandula Angustifolia (Lavender) Flower Water

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

• instant hand antiseptic to reduce bacteria that potentially can cause disease

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 70% v/v

Other Information

• Store between 15-30C (59-86F)

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

Inactive Ingredient (INACTIVE INGREDIENT)

Water, Glycerin, Flavor, Rosmarinus Officinalis (Rosemary) Extract, Camellia Sinensis Leaf Extract, Lavandula Angustifolia (Lavender) Flower 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 (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)


Advanced Ingredient Data


Raw Label Data

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