SAFMAXX HAND SANITIZER- benzalkonium chloride liquid

SAFMAXX Hand Sanitizer by

Drug Labeling and Warnings

SAFMAXX Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by G&N Enterprise,LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Benzalkonium Chloride 0.13%

PURPOSE

Purpose

Antiseptic

INDICATIONS & USAGE

Uses

• handwash to help reduce bacteria that potentially can cause disease

• helps to prevent cross-contamination by hand contact

• helps to prevent drying of the skin

• recommended for repeated use

WARNINGS

Warnings

For external use only

When using this product do not use in or near eyes

Stop use and ask a doctor if irritation or redness develop.

Keep out of reach of children.

If swallowed, seek medical attention or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION

Directions

• apply appropriate amount of product into palm of hand

• rub thouroughtly over all surfaces of both hands for at least 20 seconds
• rub hands together until dry

STORAGE AND HANDLING

Other information

store in a cool, dry place below 104 o F (40 o C)

INACTIVE INGREDIENT

Inactive ingredients

Water, cocamidopropyl betaine, glycerine, polozamer 124, benzyl alcohol, phenoxyethanol,FD&C Blue No.1

QUESTIONS

Questions?

Contact G&N Enterprise, LLC at 800-290-6816 Mon-Fri 9 am-5 pm CST

PRINCIPAL DISPLAY PANEL

SAFMAXX

Hand Sanitizer

Non_Alcohol

Microbiological Shield

Made in the USA

Benzalkonium Chloride 0.13%

INGREDIENTS AND APPEARANCE

SAFMAXX HAND SANITIZER 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69731-041
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)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
GLYCERIN (UNII: PDC6A3C0OX)
POLOXAMER 124 (UNII: 1S66E28KXA)
BENZYL ALCOHOL (UNII: LKG8494WBH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69731-041-21	946352 mL in 1 TANK; Type 0: Not a Combination Product	05/01/2020
2	NDC: 69731-041-22	208197 mL in 1 DRUM; Type 0: Not a Combination Product	05/01/2020
3	NDC: 69731-041-23	3785 mL in 1 JUG; Type 0: Not a Combination Product	05/01/2020
4	NDC: 69731-041-25	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2020
5	NDC: 69731-041-28	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2020
6	NDC: 69731-041-20	45 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2020
7	NDC: 69731-041-29	20 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2020
8	NDC: 69731-041-27	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2020
9	NDC: 69731-041-24	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2020
10	NDC: 69731-041-26	1893 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/01/2020

Labeler - G&N Enterprise,LLC (079758164)

Registrant - G&N Enterprise,LLC (079758164)