SPL v2
SPL
SPL Set ID a250511f-5a8e-7769-e053-2995a90a0469
Route
TOPICAL
Published
Effective Date 2020-04-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (0.2 mL)
Inactive Ingredients
Butylene Glycol Pantolactone, (r)- Carbomer Homopolymer, Unspecified Type 1,2-hexanediol Tromethamine Tea Tree Oil Alpha-tocopherol Acetate Water Glycerin Chamaecyparis Obtusa Leaf Lemon Oil Panthenol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-04-10

Description

Squeeze a dime-sized drop on hands and rub together. Allow to dry without wiping off.

Purpose

Anticeptic


Medication Information

Purpose

Anticeptic

Description

Squeeze a dime-sized drop on hands and rub together. Allow to dry without wiping off.

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external Use Only. Flammable. Keep away from fire or flame.

Directions

Squeeze a dime-sized drop on hands and rub together. Allow to dry without wiping off.

Ingredients

Water, Glycerin, Carbomer, Chamaecy paris Obtusa Leaf Extract, Tromethamine, Butylene Glycol, 1,2-H exanediol, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Citrus Limon (Lemon) Peel Oil, Tocopheryl Acetate, Panthenol, Pantolactone

Package Label

Active Ingredient

Alcohol 62%

Precautions When Using

1. When using cosmetics or after use, consult a specialist if you have any abnormal symptoms such as red spots, swelling or itching, or side effects caused by direct sunlight

​precautions When Using

Keep out of the reach of children.


Structured Label Content

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Purpose

Anticeptic

Warnings

For external Use Only. Flammable. Keep away from fire or flame.

Directions

Squeeze a dime-sized drop on hands and rub together. Allow to dry without wiping off.

Ingredients

Water, Glycerin, Carbomer, Chamaecy paris Obtusa Leaf Extract, Tromethamine, Butylene Glycol, 1,2-H exanediol, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Citrus Limon (Lemon) Peel Oil, Tocopheryl Acetate, Panthenol, Pantolactone

Package Label

Active Ingredient

Alcohol 62%

Precautions When Using (Precautions when using)

1. When using cosmetics or after use, consult a specialist if you have any abnormal symptoms such as red spots, swelling or itching, or side effects caused by direct sunlight

​precautions When Using (​Precautions when using)

Keep out of the reach of children.


Advanced Ingredient Data


Raw Label Data

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