Revitalize

Revitalize
SPL v1
SPL
SPL Set ID a83f1fb9-9115-4a65-a119-2214b74f7dd2
Route
TOPICAL
Published
Effective Date 2020-12-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 mL)
Inactive Ingredients
Water Glycerin Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-12-18

Description

Ethyl Alcohol 62%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 62%

Section 42229-5

Kills 99.9% of germs

Manufactured by:

Revive Sports, Inc.

PO Box 423

Hurricane WV 25526

www.RevitalizeSports.com

A FDA Registered Facility

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Use(s):

Hand Sanitizer to help reduce bacteria that potentially can cause disease   For use when soap and water are not available.

Warning:

For external use only. Flammable, Keep from heat and flame.

Do not use • on infants • 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 maybe signs of a serious condition.

Packaging

Drug Facts

Directions:

Apply as needed into the palm of hand and thoroughly spread on both hands, rub until dry. Supervise children under 6 years of age when using product.

Ingredients

Water, Glycerin, Carbomer 980, Triethanolamine

Active Ingredient:

Ethyl Alcohol 62%


Structured Label Content

Section 42229-5 (42229-5)

Kills 99.9% of germs

Manufactured by:

Revive Sports, Inc.

PO Box 423

Hurricane WV 25526

www.RevitalizeSports.com

A FDA Registered Facility

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Purpose

Antiseptic

Use(s):

Hand Sanitizer to help reduce bacteria that potentially can cause disease   For use when soap and water are not available.

Warning:

For external use only. Flammable, Keep from heat and flame.

Do not use • on infants • 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 maybe signs of a serious condition.

Packaging

Drug Facts (DRUG FACTS)

Directions:

Apply as needed into the palm of hand and thoroughly spread on both hands, rub until dry. Supervise children under 6 years of age when using product.

Ingredients

Water, Glycerin, Carbomer 980, Triethanolamine

Active Ingredient: (Active ingredient:)

Ethyl Alcohol 62%


Advanced Ingredient Data


Raw Label Data

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