FUBU ANTISEPTIC HAND SANITIZER WIPES- benzalkonium chloride cloth
BEEKMAN INTERNATIONAL INC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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FUBU Antiseptic Hand Sanitizer Wipes

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

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Package Labeling: 72 WIPES

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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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	01/01/2021

Labeler - BEEKMAN INTERNATIONAL INC (117679551)