Gaia Hand Sanitizer with Lemon Balm

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]

GAIA HERBS HAND SANITIZER WITH LEMON BALM- alcohol solution 
Gaia Herbs, Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Gaia Hand Sanitizer with Lemon Balm

Drug Facts

Active ingredient

Organic Alcohol 70%

Purpose

Antiseptic

Use
To help reduce germs and bacteria.

Warnings
Flammable. Keep away from fire or flame. For external use only.

When using this product keep out of eyes. In case of contact, rinse with water to remove.

Stop use and ask a doctor if irritation or redness develops and lasts more than 72 hours.

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

Directions

• Spray on hands and rub together until dry.
• For children under 6 years of age, use only under adult supervision.
• Not recommended for infants.

Other information

Do not store for long periods in excessive heat.

Inactive ingredients Organic Glycerin, Organic Lemon Balm Extract, Organic Lemon Essential Oil, Purified Water USP.

Gaia Herbs, Inc., 101 Gaia Herbs Drive, Brevard, NC 28712

Certified Organic by Oregon Tilth.

gaia® HERBS

USDA ORGANIC
HAND SANITIZER
KILLS 99.9% OF GERMS

With Gaia-grown® Lemon Balm

ALCOHOL (70%) ANTISEPTIC

6 - 2 FL OZ (59 ML) BOTTLES

GAIA HERBS HAND SANITIZER  WITH LEMON BALM
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74817-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
MELISSA OFFICINALIS (UNII: YF70189L0N)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
LEMON OIL (UNII: I9GRO824LL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74817-004-06	6 in 1 CARTON	11/12/2020	12/31/2022
1		59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
2	NDC: 74817-004-02	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	11/12/2020	12/31/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	11/12/2020	12/31/2022

Labeler - Gaia Herbs, Inc (623101664)

Establishment
Name	Address	ID/FEI	Business Operations
Gaia Herbs, Inc		623101664	manufacture(74817-004)

Revised: 12/2021

Document Id: d4629db9-463f-ff8a-e053-2995a90aae98

34390-5

Set id: b3ea0392-534d-a6b5-e053-2a95a90a35ea

Version: 3

Effective Time: 20211230