FUBU ANTISEPTIC HAND SANITIZER WIPES- benzalkonium chloride cloth

FUBU Antiseptic Hand Sanitizer Wipes by

Drug Labeling and Warnings

FUBU Antiseptic Hand Sanitizer Wipes by is a Otc medication manufactured, distributed, or labeled by BEEKMAN INTERNATIONAL INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Benzalkonium chloride 0.13%

Purpose

Antiseptic

Use

For hand washing to decrease bacteria on the skin

Warnings

For external use only

Do not use

in the eyes

Stop use and ask a doctor if

• irritation and redness develop
• condition 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

• wet hands thoroughly with product and allow to dry without wiping

Other information

• Store at room temperature.
• Keep lid tightly closed when not in use.

Inactive ingredients

Benzoic Acid, C12-15 Pareth 12, Citric Acid, Dehydroacetic Acid, Fragrance, Glycerin, Phenoxyethanol, Water.

Package Labeling: 15 WIPES

Package Labeling: 72 WIPES

INGREDIENTS AND APPEARANCE

FUBU ANTISEPTIC HAND SANITIZER WIPES 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81321-000
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
BENZOIC ACID (UNII: 8SKN0B0MIM)
C12-15 PARETH-12 (UNII: 131316X18L)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81321-000-01	15 in 1 POUCH	01/01/2021
1		1.8 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2	NDC: 81321-000-02	72 in 1 POUCH	01/01/2021
2		3.47 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	01/01/2021

Labeler - BEEKMAN INTERNATIONAL INC (117679551)