SPL v2
SPL
SPL Set ID a4a675f8-5edb-6aa0-e053-2995a90a6280
Route
TOPICAL
Published
Effective Date 2020-05-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70.00075 mL)
Inactive Ingredients
Carbomer Homopolymer, Unspecified Type Fragrance Lavender & Chia F-153480 Trolamine Aloe Vera Leaf Petroselinum Crispum Glycerin Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-05-08

Description

Ethyl Alcohol 70%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 70%

Use

Hand sanitizer to help reduce bacteria that potentially can cause disease.

Warnings

For external use only. Flammable. Keep away from heat or flame.

Directions

Wet hands thoroughly with product and allow to dry without wiping.

For children under 6, use only under adult supervision.

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

Purified Water, Glycerin, Carbomer, Fragrance, Trolamine, Aleo Extract(09), Parsley Extract

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 Poison Control Center right away.


Structured Label Content

Use

Hand sanitizer to help reduce bacteria that potentially can cause disease.

Purpose

Antiseptic

Warnings

For external use only. Flammable. Keep away from heat or flame.

Directions

Wet hands thoroughly with product and allow to dry without wiping.

For children under 6, use only under adult supervision.

Do Not Use (Do not use)

in children less than 2 months of age

on open skin wounds

Package Label

Active Ingredient (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 (Inactive ingredients)

Purified Water, Glycerin, Carbomer, Fragrance, Trolamine, Aleo Extract(09), Parsley Extract

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 Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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