SPL v1
SPL
SPL Set ID a250577c-2ff4-757c-e053-2a95a90ad88b
Route
CUTANEOUS
Published
Effective Date 2020-04-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62.035 mL)
Inactive Ingredients
Water Glycerin Hyaluronate Sodium 1,2-hexanediol Propylene Glycol Coptis Japonica Root Propolis Wax Butylene Glycol Caprylyl Glycol Trolamine Carbomer Homopolymer, Unspecified Type Panthenol Glycyrrhiza Glabra Schisandra Chinensis Fruit Ginger Green Tea Leaf Asiaticoside Grapefruit Pine Needle Oil (pinus Sylvestris)

Identifiers & Packaging

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

Description

Ethyl alcohol 62%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethyl alcohol 62%

Uses

to decrease bacteria on the skin that could cause disease

recommended for repeated use

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

Active Ingredient

Ethyl alcohol 62%

Other Information

do not store above 105F

may discolor some fabrics

harmful to wood finishes and plastics

Inactive Ingredients

Water, Sodium Hyaluronate, Glycerin, 1,2-Hexanediol, Triethanolamine, Carbomer, Panthenol, Propylene Glycol, Glycyrrhiza Glabra (licorice) Root Extract, Zingiber Officinale (Ginger) Root Extract, Schisandra Chinensis Fruit Extract, Coptis Japonica Root Extract, Camellia Sinensis Leaf Extract, Propolis Wax, Butylene Glycol, Asiaticoside, Citrus Paradisi (Grapefruit) Fruit Extract, Pinus Sylvestris Leaf Extract, Caprylyl Glycol

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

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


Structured Label Content

Uses

to decrease bacteria on the skin that could cause disease

recommended for repeated use

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

Active Ingredient

Ethyl alcohol 62%

Other Information (Other information)

do not store above 105F

may discolor some fabrics

harmful to wood finishes and plastics

Inactive Ingredients (Inactive ingredients)

Water, Sodium Hyaluronate, Glycerin, 1,2-Hexanediol, Triethanolamine, Carbomer, Panthenol, Propylene Glycol, Glycyrrhiza Glabra (licorice) Root Extract, Zingiber Officinale (Ginger) Root Extract, Schisandra Chinensis Fruit Extract, Coptis Japonica Root Extract, Camellia Sinensis Leaf Extract, Propolis Wax, Butylene Glycol, Asiaticoside, Citrus Paradisi (Grapefruit) Fruit Extract, Pinus Sylvestris Leaf Extract, Caprylyl Glycol

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)

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


Advanced Ingredient Data


Raw Label Data

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