SAFESURE HAND SANITIZER- benzalkonium chloride liquid

Safesure hand sanitizer by

Drug Labeling and Warnings

Safesure hand sanitizer by is a Otc medication manufactured, distributed, or labeled by SAFE SURE USA, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Benzalkonium Chloride 1.3%

PURPOSE

Use

Helps reduce bacteria on the skin. Recommended for repeated use.

WARNINGS

KEEP OUT OF REACH OF CHILDREN

Directions

Apply product to hands and rub until dry.

STORAGE
Store in cool dry place between 35°F and 103°F.

Inactive ingredients

Deionized Water, Propylene Glycol, Triethylene Glycol, Phospholipids Complex, Organo Silane Quaternaries

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

SAFESURE HAND SANITIZER 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80852-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TRIETHYLENE GLYCOL (UNII: 3P5SU53360)
PEG-75 LANOLIN (UNII: 09179OX7TB)
DIMETHYLOCTADECYL(3-(TRIMETHOXYSILYL)PROPYL)AMMONIUM CHLORIDE (UNII: IQ36O85WQ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80852-001-01	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/09/2020
2	NDC: 80852-001-02	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/09/2020
3	NDC: 80852-001-03	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/09/2020
4	NDC: 80852-001-04	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/09/2020
5	NDC: 80852-001-05	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/09/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/09/2020

Labeler - SAFE SURE USA, INC. (117624760)