HAND SANITIZER FRESH- benzalkonium chloride gel

Hand Sanitizer Fresh by

Drug Labeling and Warnings

Hand Sanitizer Fresh by is a Otc medication manufactured, distributed, or labeled by Harmonia de Venezuela CA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient                                                        Purpose

Benzalkonium Chloride (0.1 %)--------------------- Antimicrobial

PURPOSE

Uses

For hand sanitizing to decrease bacteria on the skin.

Warnings

For external uses only. / When using this products avoid contact of eyes. In case of eye contact, flush eyes with water. / Stop use and ask a doctor if irritation or redness develops, or if conditions persists for more than 72 hours. /Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply a small amount into palm of hands and rub hands together briskly until dry.

KEEP OUT OF REACH OF CHILDREN

Inactive Ingredients

water, glycerin, hydroxypropyl methylcellulose, PEG-12 dimethicone, fragance, DMDM hydantoin, FD&C Blue No. 1 

Principal display panel

INGREDIENTS AND APPEARANCE

HAND SANITIZER FRESH 
benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73360-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)
DMDM HYDANTOIN (UNII: BYR0546TOW)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73360-003-01	4 in 1 CARTON	09/20/2019
1		28 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 73360-003-02	100 in 1 CARTON	09/20/2019
2		3 mL in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 73360-003-03	28 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/20/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/20/2019

Labeler - Harmonia de Venezuela CA (817307290)

Establishment
Name	Address	ID/FEI	Business Operations
Harmonia de Venezuela CA		817307290	manufacture(73360-003)