SPL v1
SPL
SPL Set ID 051d096f-ae69-4493-a4f5-c36695f885d7
Route
TOPICAL
Published
Effective Date 2020-05-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (310 mL)
Inactive Ingredients
Water Carbomer Homopolymer, Unspecified Type Trolamine Glycerin .alpha.-tocopherol Acetate Salvia Officinalis Root Hedera Helix Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-05-01

Description

Alcohol 62% v/v

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Alcohol 62% v/v

Uses

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

For use when soap and water are not available.

Warnings

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

Do not use

■ in children less than 2 months of age ■ on open skin wounds

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.

Directions

■ Place enough product on hands to cover all surfaces. Rub hands together until dry.

■Supervise children under 6 years of age when using this product to avoid swallowing.

■ Avoid direct inhalation of vapors during application. (Headaches and irritation to mucous membranes may occur when directly inhaled.)

■ This product is intended only for hand sanitizing.

■ To prevent contents from drying out and contaminants from entering, close lid completely after use.

■ Keep product in its original container as storing the product in anything other than the original container may result in accidents or cause the integrity of the product to diminish.

■ Do not use over bandages, castings, etc. as irritation may occur.

Active Ingredient

Alcohol 62% v/v

Other Information

■ Store between 15-30 ℃ (59-86 °F)

■ Avoid freezing and excessive heat above 40 ℃ (104 °F)

Inactive Ingredient

Water, Carbomer, Triethanolamine, Glycerin, Tocopheryl Acetate, Salvia Officinalis (Sage) Extract, Hedera Helix (Ivy) Extract

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

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

For use when soap and water are not available.

Purpose (PURPOSE)

Antiseptic

Warnings (WARNINGS)

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

Do not use

■ in children less than 2 months of age ■ on open skin wounds

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.

Directions

■ Place enough product on hands to cover all surfaces. Rub hands together until dry.

■Supervise children under 6 years of age when using this product to avoid swallowing.

■ Avoid direct inhalation of vapors during application. (Headaches and irritation to mucous membranes may occur when directly inhaled.)

■ This product is intended only for hand sanitizing.

■ To prevent contents from drying out and contaminants from entering, close lid completely after use.

■ Keep product in its original container as storing the product in anything other than the original container may result in accidents or cause the integrity of the product to diminish.

■ Do not use over bandages, castings, etc. as irritation may occur.

Active Ingredient (ACTIVE INGREDIENT)

Alcohol 62% v/v

Other Information (Other information)

■ Store between 15-30 ℃ (59-86 °F)

■ Avoid freezing and excessive heat above 40 ℃ (104 °F)

Inactive Ingredient (INACTIVE INGREDIENT)

Water, Carbomer, Triethanolamine, Glycerin, Tocopheryl Acetate, Salvia Officinalis (Sage) Extract, Hedera Helix (Ivy) Extract

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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