73549-015

73549-015
SPL v3
SPL
SPL Set ID c5d09234-0294-853b-e053-2995a90acfef
Route
TOPICAL
Published
Effective Date 2020-08-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Fd&c Yellow No. 5 Butylene Glycol Caprylhydroxamic Acid Edetate Disodium Anhydrous Aloe Vera Whole Fd&c Blue No. 1 .alpha.-tocopherol Acetate Fragrance Floral Orc0902236 Water Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Aminomethylpropanol Polyoxyl 40 Hydrogenated Castor Oil 1,2-hexanediol Citric Acid Monohydrate D&c Red No. 33

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-07-30

Description

Ethyl Alcohol 70%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 70%

Use

■For handwashing to decrease bacteria on the skin.

Warnings

For external use only: hands

Flammable, keep away from fire or flame

Directions

■wet hands thoroughly with product and allow to dry without wiping

■for children under 6, use only under adult supervision

■not recommended for infants

Package Label

73549-015-01 30ml

Active Ingredient

Ethyl Alcohol 70%

Other Information

■do not store above 105°F

■may discolor some fabrics

■harmful to wood finishes and plastics

Inactive Ingredients

Water(Aqua), PEG-40 Hydrogenated Castor Oil, Fragrance(Parfum) , Acrylates/ C10-30Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Aloe Barbadensis Extract, Butylene Glycol, 1,2-Hexanediol, Caprylhydroxamic Acid, Citric Acid, Disodium EDTA, Tocopheryl Acetate, Red 33, Yellow 5, Blue 1

When Using This Product

■keep out of eyes.In case of contact with eyes flush thoroughly with water.

■avoid contact with broken skin

■do not inhale or ingest

Stop Use and Ask A Doctor If

■irritation and redness develop

■condition persists for more than 72 hours

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.


Structured Label Content

Use

■For handwashing to decrease bacteria on the skin.

Purpose

Antiseptic

Warnings

For external use only: hands

Flammable, keep away from fire or flame

Directions

■wet hands thoroughly with product and allow to dry without wiping

■for children under 6, use only under adult supervision

■not recommended for infants

Package Label

73549-015-01 30ml

Active Ingredient (Active ingredient)

Ethyl Alcohol 70%

Other Information (Other information)

■do not store above 105°F

■may discolor some fabrics

■harmful to wood finishes and plastics

Inactive Ingredients (Inactive ingredients)

Water(Aqua), PEG-40 Hydrogenated Castor Oil, Fragrance(Parfum) , Acrylates/ C10-30Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Aloe Barbadensis Extract, Butylene Glycol, 1,2-Hexanediol, Caprylhydroxamic Acid, Citric Acid, Disodium EDTA, Tocopheryl Acetate, Red 33, Yellow 5, Blue 1

When Using This Product (When using this product)

■keep out of eyes.In case of contact with eyes flush thoroughly with water.

■avoid contact with broken skin

■do not inhale or ingest

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

■irritation and redness develop

■condition persists for more than 72 hours

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.


Advanced Ingredient Data


Raw Label Data

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