SPL v1
SPL
SPL Set ID 90839fe9-df8e-4e3d-a9e3-eb714f62bde6
Route
TOPICAL
Published
Effective Date 2020-06-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (0.70 1)
Inactive Ingredients
Water Glycerin Chamaemelum Nobile Flower Melaleuca Alternifolia Leaf .alpha.-hexylcinnamaldehyde Isomethyl-.alpha.-ionone Aloe Vera Leaf Hyaluronic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-06-01

Description

Ethyl alcohol 70%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethyl alcohol 70%

Uses

ㆍto decrease bacteria on the skin that could cause disease

ㆍrecommended for repeated use

Warnings

For external use only: hands

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Flammable. Keep away from fire or flame

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When using this product

ㆍkeep out of eyes. In case of contact with eyes, flush thoroughly with water.

ㆍavoid contact with broken skin ㆍdo not inhale or ingest

--------------------------------------------------------------------------------------------------------

Stop use and ask a doctor if 

ㆍirritation or redness develops ㆍcondition persists for more than 72 hours

Directions

ㆍuse towelette to throughly wipe hands or surfaces

ㆍfor children under 6, use only under adult supervision

ㆍnot recommended for infants

Active Ingredient

Ethyl alcohol 70%

Other Information

ㆍstore below 110℉ (43℃) ㆍmay discolor some fabrics

ㆍharmful to wood finishes and plastics

Inactive Ingredient

Aqua/Water, Glycerin, Cymbopogon Citratus Extract, Anthemis Nobilis Flower Extract, Aspalathus Linearis Extract, Melaleuca Alternifolia (Tea Tree) Leaf Extract, Hexyl Cinnamal, Alpha-Isomethyl Ionone, Fragrance, Aloe Barbadensis Extract, Hyaluronic Acid

Keep Out of Reach of Children

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

Package Label.principal Display Panel


Structured Label Content

Uses

ㆍto decrease bacteria on the skin that could cause disease

ㆍrecommended for repeated use

Purpose (PURPOSE)

Antiseptic

Warnings (WARNINGS)

For external use only: hands

--------------------------------------------------------------------------------------------------------

Flammable. Keep away from fire or flame

--------------------------------------------------------------------------------------------------------

When using this product

ㆍkeep out of eyes. In case of contact with eyes, flush thoroughly with water.

ㆍavoid contact with broken skin ㆍdo not inhale or ingest

--------------------------------------------------------------------------------------------------------

Stop use and ask a doctor if 

ㆍirritation or redness develops ㆍcondition persists for more than 72 hours

Directions

ㆍuse towelette to throughly wipe hands or surfaces

ㆍfor children under 6, use only under adult supervision

ㆍnot recommended for infants

Active Ingredient (ACTIVE INGREDIENT)

Ethyl alcohol 70%

Other Information

ㆍstore below 110℉ (43℃) ㆍmay discolor some fabrics

ㆍharmful to wood finishes and plastics

Inactive Ingredient (INACTIVE INGREDIENT)

Aqua/Water, Glycerin, Cymbopogon Citratus Extract, Anthemis Nobilis Flower Extract, Aspalathus Linearis Extract, Melaleuca Alternifolia (Tea Tree) Leaf Extract, Hexyl Cinnamal, Alpha-Isomethyl Ionone, Fragrance, Aloe Barbadensis Extract, Hyaluronic Acid

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.

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)


Advanced Ingredient Data


Raw Label Data

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