SPL v1
SPL
SPL Set ID a532b74e-8585-7ac7-e053-2995a90a1484
Route
TOPICAL
Published
Effective Date 2020-05-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Allantoin Hyaluronate Sodium Water Poliglusam Hydrochloride Hamamelis Virginiana Top Carbomer Homopolymer, Unspecified Type

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-05-13

Description

Ethyl Alcohol 70%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 70%

Uses

Hand Sanitizer to reduce bacteria on the skin

Warnings

For external use only: hands

Flammable, keep away from heat and 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 70%

Other Information

Do not store above 105F. May discolor certain fabrics.

Inactive Ingredients

Water, Sodium Hyaluronate, Chitosan, Allantoin, Hamamelis Virginiana (Witch Hazel) Extract, Carbomer

When Using This Product

Keep out of eyes. In case of contact with eyes, nise thoroughly with water. Do not inhale or ingest.

Stop Use and Ask A Doctor If

Irritation or redness develops. 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

Hand Sanitizer to reduce bacteria on the skin

Purpose

Antiseptic

Warnings

For external use only: hands

Flammable, keep away from heat and 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 70%

Other Information (Other information)

Do not store above 105F. May discolor certain fabrics.

Inactive Ingredients (Inactive ingredients)

Water, Sodium Hyaluronate, Chitosan, Allantoin, Hamamelis Virginiana (Witch Hazel) Extract, Carbomer

When Using This Product (When using this product)

Keep out of eyes. In case of contact with eyes, nise thoroughly with water. Do not inhale or ingest.

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

Irritation or redness develops. 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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