WALTZ FREE HAND SANITIZER- benzalkonium chloride lotion

Waltz Free Hand Sanitizer by

Drug Labeling and Warnings

Waltz Free Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by AvKARE. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS

Active Ingredient

Benzalkonium chloride 0.13%

Purpose

Antiseptic

Uses

Kills 99.99 % germs and moisturizes skin.

Warnings

For external use only.

Do not use in the eyes.

In case of eye contact, rinse eyes thoroughly with water.

Stop use and ask a doctor

if irritation or redness develops, or if condition persists more than 72 hours.

Keep out of reach of children.

Instruct children on proper use. If swallowed, get medical help or contact a Poison Control Center right away.

To report SUSPECTED ADVERSE REACTIONS contact AvKARE, Inc. at 1-855-361-3993 or email drugsafety@avkare.com.

Directions

Apply a small amount to hands every 3 to 4 hours and rub until dry. Does not replace soap and water. 

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Avena Sativa (Oat) Extract, Behentrimonium Methosulfate, Butylene Glycol, Caprylyl Glycol, Centrimonium Chloride, Dimethicone, Emulsifying Wax NF, Glycerin, Hydrolyzed Soy Protein, Mentha Piperita (Peppermint) Essential Oil, Phenoxyethanol, Retinyl Palmitate Vitamin A, Simmondsia Chinensis (Jojoba) Seed Oil, Sorbic Acid, Tetrasodium EDTA, Tocopheryl Acetate Vitamin E, Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

WALTZ FREE HAND SANITIZER 
benzalkonium chloride lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73190-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.0013 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
AVENA SATIVA LEAF (UNII: 206PI19V7R)
BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
SOY PROTEIN (UNII: R44IWB3RN5)
PEPPERMINT OIL (UNII: AV092KU4JH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
JOJOBA OIL (UNII: 724GKU717M)
SORBIC ACID (UNII: X045WJ989B)
EDETATE SODIUM (UNII: MP1J8420LU)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73190-001-01	44.3 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/13/2019
2	NDC: 73190-001-02	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/13/2019
3	NDC: 73190-001-16	473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/13/2019
4	NDC: 73190-001-27	800 mL in 1 BAG; Type 0: Not a Combination Product	08/13/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/13/2019

Labeler - AvKARE, Inc (796560394)