ANTIBACTERIAL FOAMING HAND SANITIZER- benzalkonium chloride liquid

Antibacterial Foaming Hand Sanitizer by

Drug Labeling and Warnings

Antibacterial Foaming Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Maketa,LLC, BMC 1092, Inc. dba Solo Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Benzalkonium Chloride

Purpose

Antimicrobial

Uses

Sanitizes hands to help reduce bacteria that potentially cause diseases.

Warnings

For External use only. Use on hands only. Do not use over large areas of the body.

Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.

Stop Use and ask a doctor if irritation and redness develops , or persist 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

Place enough product in your palm to thoroughly cover your hands. Rub hands together briskly until hands are entirely dry.

Other information

Store at room temperature.

Inactive Ingredients

Leaf Juice, Water, Glycerin, Aloe Barbadensis Bisabolol , PEG-8, Disodium EDTA, Polysorbate-20, PEG-40, Sorbitan Peroleate, Allantoin, Sodium Benzoate, Fragrance

Questions?

(800) 638-8149

PRINCIPAL DISPLAY PANEL - 281 ml Bottle Label

Makéta™

antimicrobial
FOAMING HAND
SANITIZER

kills 99.99%
of all germs

9.5 fl. oz. (281 ml)

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL FOAMING HAND SANITIZER 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72102-056
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)
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)
Allantoin (UNII: 344S277G0Z)
Aloe vera leaf (UNII: ZY81Z83H0X)
Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)
PEG-8 Stearate (UNII: 2P9L47VI5E)
PEG-40 Sorbitan diisostearate (UNII: JL4CCU7I1G)
Glycerin (UNII: PDC6A3C0OX)
Sodium Benzoate (UNII: OJ245FE5EU)
Polysorbate 20 (UNII: 7T1F30V5YH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72102-056-09	281 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/20/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part333E	04/20/2020

Labeler - Maketa,LLC (081031516)

Registrant - BMC 1092, Inc. dba Solo Laboratories, Inc. (078831987)

Establishment
Name	Address	ID/FEI	Business Operations
BMC 1092, Inc. dba Solo Laboratories, Inc.		078831987	MANUFACTURE(72102-056) , LABEL(72102-056) , PACK(72102-056)