GAIA HERBS HAND SANITIZER- alcohol solution

Gaia Herbs Hand Sanitizer by

Drug Labeling and Warnings

Gaia Herbs Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Gaia Herbs, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Organic Alcohol 80% v/v

PURPOSE

Purpose

Antiseptic

INDICATIONS & USAGE

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

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.

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

DOSAGE & ADMINISTRATION

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.

STORAGE AND HANDLING

Other information

• Store between 15°-30°C (59°-86°F)
• Avoid freezing and excessive heat above 40°C (104°F)

INACTIVE INGREDIENT

Inactive ingredients glycerin, hydrogen peroxide, purified water USP

SPL UNCLASSIFIED SECTION

Gaia Herbs, Inc.

101 Gaia Herbs Drive

Brevard, NC 28712

PRINCIPAL DISPLAY PANEL

gaia® HERBS
HAND SANITIZER
Alcohol Antiseptic 80%

Topical Solution
Non-sterile Solution

2 FL OZ (59 mL)

INGREDIENTS AND APPEARANCE

GAIA HERBS HAND SANITIZER 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74817-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74817-003-02	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/21/2020
2	NDC: 74817-003-01	3790 mL in 1 JUG; Type 0: Not a Combination Product	04/21/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	04/21/2020

Labeler - Gaia Herbs, Inc (623101664)

Establishment
Name	Address	ID/FEI	Business Operations
Gaia Herbs, Inc		623101664	manufacture(74817-003)