TOPSANI by Prime Enterprises TOPSANI hand Sanitizer

TOPSANI by

Drug Labeling and Warnings

TOPSANI by is a Otc medication manufactured, distributed, or labeled by Prime Enterprises. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TOPSANI- benzalkonium chloride gel 
Prime Enterprises

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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TOPSANI hand Sanitizer

Active Ingredients

Benzalkonium Chloride 0.125%​

Purpose

Antomicrobial

Indications

For Handwashing to decrease bacteria

Warning

For external use only.

When using this product avoid contact with the eyes. Rinse with water to remove.

Stop use and ask a doctor if rash or irritation develops and lasts.

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.​

Inactive Ingredients

Blue 1, Fragrance, Hydroxypropyl Methylcellulose, Polysorbate 20, SD Alcohol 40-B, Urea, Water ​

Questions or comments

Call 1-877-541-6055​

Keep out of reach of children

Keep out of reach of children. If swallowed get medical help or contact a poison control center right away.​

Instructions

Wet hands thoroughly with product and allow to dry without wiping.​

Principal Display Label

TOPSANI 
benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0335
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
UREA (UNII: 8W8T17847W)
ALCOHOL (UNII: 3K9958V90M)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
WATER (UNII: 059QF0KO0R)
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)
POLYSORBATE 20 (UNII: 7T1F30V5YH)

Product Characteristics
Color	blue (Light Blue)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0335-4	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/27/2020	07/31/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/27/2020	07/31/2022

Labeler - Prime Enterprises (101946028)

Registrant - Prime Enterprises (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises		101946028	manufacture(58443-0335) , pack(58443-0335) , analysis(58443-0335) , label(58443-0335)

Revised: 4/2022

Document Id: dbea1faf-5c40-6ddd-e053-2a95a90ad545

34390-5

Set id: a6a4700d-f844-1229-e053-2995a90a4c7e

Version: 2

Effective Time: 20220405