HEALTHY SPIRIT- alcohol gel
K2 HEALTH PRODUCTS LLC

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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Active Ingredient

Benzalkonium chloride 0.13%

Purpose

Antiseptic

Use

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

Warnings

Do not freeze. For external use only.

Do not use

in children less than 2 months of age
in ears or mouth

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.

Children should be supervised when using this product.

Directions

Apply a small amount into palms and spread on both hands. Rub into skin until dry.

Inactive ingredients

Isopropyl alcohol, Hydroxyethyl celleulose, glycerin, methylparaben, propylparaben, Propylene glycol, Dmdm hydantoin, FD&C Blue no 1

Package Label - Principal Display Panel

Product label

HEALTHY SPIRIT
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73745-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DMDM HYDANTOIN (UNII: BYR0546TOW)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:73745-001-01	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/12/2020
2	NDC:73745-001-02	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/19/2020
3	NDC:73745-001-03	3000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/19/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	05/12/2020

Labeler - K2 HEALTH PRODUCTS LLC (800616612)