GAIA HERBS HAND SANITIZER- alcohol solution GAIA HERBS ANTISEPTIC HAND RUB- alcohol solution

Gaia Herbs Antiseptic Hand Rub by

Drug Labeling and Warnings

Gaia Herbs Antiseptic Hand Rub 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

Alcohol 80% v/v

PURPOSE

Purpose

Antiseptic

INDICATIONS & USAGE

Use
HAND SANITIZER: Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
ANTISEPTIC HAND RUB: Healthcare personnel hand rub to help reduce bacteria that potentially can cause disease.

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)

PRINCIPAL DISPLAY PANEL

gaia® HERBS
ANTISEPTIC HAND RUB
Alcohol Antiseptic 80%
Topical Solution
Non-Sterile Solution
1 GALLON (3.79 L)

INGREDIENTS AND APPEARANCE

GAIA HERBS HAND SANITIZER 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74817-001
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: 74817-001-02	59 mL in 1 BOTTLE, PLASTIC; 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

GAIA HERBS ANTISEPTIC HAND RUB 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74817-002
Route of Administration	TOPICAL

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74817-002-01	3.79 L 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(74817-001, 74817-002)