SPL v1
SPL
SPL Set ID c01cf926-86f9-4b74-8dd6-0efa4adc690a
Route
TOPICAL
Published
Effective Date 2020-05-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (350 mL)
Inactive Ingredients
Water Glycerin Carbomer Homopolymer, Unspecified Type Trolamine Methylpropanediol 1,2-hexanediol Aloe Vera Leaf Benzyl Benzoate Benzyl Salicylate .beta.-citronellol, (r)- Limonene, (+)- .alpha.-hexylcinnamaldehyde Linalool, (+/-)-

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-05-01

Description

Alcohol 70% v/v

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Alcohol 70% v/v

Uses

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

• Helps keep your uncomfortable hands fresh and clean

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.

• When using for the first time, apply it to small areas to check for skin problems.

• Refrain from using on areas with scars.

Questions?

Tel: +82-70-4249-7639

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, Polyglutamic Acid, Carbomer, Tromethamine, Methylpropanediol, 1,2-Hexanediol, Aloe Barbadensis Leaf Water, Fragrance(Perfume), Benzyl Benzoate, Benzyl Salicylate, Citronellol, Limonene, Hexyl Cinnamal, Linalool

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.

• Helps keep your uncomfortable hands fresh and clean

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

• 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.

• When using for the first time, apply it to small areas to check for skin problems.

• Refrain from using on areas with scars.

Questions?

Tel: +82-70-4249-7639

Active Ingredient (ACTIVE INGREDIENT)

Alcohol 70% v/v

Other Information (Other information)

• Store between 15-30C (59-86F)

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

Inactive Ingredient (INACTIVE INGREDIENT)

Water, Glycerin, Polyglutamic Acid, Carbomer, Tromethamine, Methylpropanediol, 1,2-Hexanediol, Aloe Barbadensis Leaf Water, Fragrance(Perfume), Benzyl Benzoate, Benzyl Salicylate, Citronellol, Limonene, Hexyl Cinnamal, Linalool

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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