5173e084-fb0b-437a-a387-dfe908d2191f

SPL v1
SPL
SPL Set ID 5173e084-fb0b-437a-a387-dfe908d2191f
Route
topical
Published
Effective Date 2020-06-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (70 mL)
Inactive Ingredients
water glycerin carbomer homopolymer, unspecified type trolamine lemon oil, terpeneless citral

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-06-01

Purpose

ANTISEPTIC

Description

Ethanol 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 that potentially can cause disease.

Purpose

ANTISEPTIC

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.

Other Information

• Store between 15-30C (59-86F)

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

Inactive Ingredients

Water, Glycerin, Carbopol, Triethylamine, Lemon peel oil, Limonen, Citral

Description

Ethanol 70% v/v

Active Ingredient

Ethanol 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


Structured Label Content

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.

Uses

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

Purpose (PURPOSE)

ANTISEPTIC

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.

Other Information (Other information)

• Store between 15-30C (59-86F)

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

Inactive Ingredients (INACTIVE INGREDIENTS)

Water, Glycerin, Carbopol, Triethylamine, Lemon peel oil, Limonen, Citral

Active Ingredient (ACTIVE INGREDIENT)

Ethanol 70% v/v

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

All Sections (JSON)