79547-201

79547-201
SPL v4
SPL
SPL Set ID aa10fb97-192b-0365-e053-2995a90a648f
Route
TOPICAL
Published
Effective Date 2020-07-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (71.25 mL)
Inactive Ingredients
Trolamine Hyaluronate Sodium Centella Asiatica Butylene Glycol Carbomer Interpolymer Type A (55000 Cps) 1,2-hexanediol Carbomer Homopolymer, Unspecified Type Water Green Tea Leaf Aloe Vera Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-07-10

Description

Ethyl Alcohol 70%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 70%

Uses

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

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.

Do Not Use

in children less than 2 months of age.

on open skin wounds.

Package Label

Active Ingredient

Ethyl Alcohol 70%

Other Information

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

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

Inactive Ingredients

Water, Sodium Hyaluronate, Camellia Sinensis Leaf Extract, Centella Asiatica Extract, Aloe Barbadensis Leaf Extract, Butylene Glycol, Carbomer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, 1,2-Hexanediol, Triethanolamine, Fragrance (Lime)

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 Posion Control Center right away.


Structured Label Content

Uses

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

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.

Do Not Use (Do not use)

in children less than 2 months of age.

on open skin wounds.

Package Label

Active Ingredient

Ethyl Alcohol 70%

Other Information (Other information)

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

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

Inactive Ingredients

Water, Sodium Hyaluronate, Camellia Sinensis Leaf Extract, Centella Asiatica Extract, Aloe Barbadensis Leaf Extract, Butylene Glycol, Carbomer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, 1,2-Hexanediol, Triethanolamine, Fragrance (Lime)

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 Posion Control Center right away.


Advanced Ingredient Data


Raw Label Data

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