74454-319

74454-319
SPL v9
SPL
SPL Set ID a2c8304b-9599-17c1-e053-2995a90a1132
Route
TOPICAL
Published
Effective Date 2020-05-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (0.1 mL)
Inactive Ingredients
Alpha-tocopherol Acetate Pantolactone, (r)- Butylene Glycol Lemon Oil Tea Tree Oil Water Carbomer Homopolymer, Unspecified Type Glycerin Tromethamine Panthenol Chamaecyparis Obtusa Leaf 1,2-hexanediol

Identifiers & Packaging

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

Description

Alcohol 70%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Alcohol 70%

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 heat or flame.

Directions

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

Do Not Use

in children less than 2 months of age

on open skin wounds

Package Label

Active Ingredient

Alcohol 70%

Other Information

Store between 15-30C (59-86F)

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

Inactive Ingredient

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

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.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.


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

Antiseptic

Warnings

For external use only. Flammable. Keep away from heat or flame.

Directions

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

Do Not Use (Do not use)

in children less than 2 months of age

on open skin wounds

Package Label

Active Ingredient

Alcohol 70%

Other Information (Other information)

Store between 15-30C (59-86F)

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

Inactive Ingredient

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

When Using This Product (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 (Stop use and ask a doctor)

if irritation or rash occurs. These may be signs of a serious condition.

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.


Advanced Ingredient Data


Raw Label Data

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