Sanibelle Hand Sanitizer 50 Single Use vials per 1mL ea

Sanibelle Hand Sanitizer 50 Single Use Vials x 1mL ea by

Drug Labeling and Warnings

Sanibelle Hand Sanitizer 50 Single Use Vials x 1mL ea by is a Otc medication manufactured, distributed, or labeled by Unipharma, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SANIBELLE HAND SANITIZER 50 SINGLE USE VIALS X 1ML EA- benzalkonium chloride solution 
Unipharma, LLC

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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Sanibelle Hand Sanitizer 50 Single Use vials per 1mL ea

Active Ingredient(s)

Benzalkonium Chloride 0.13%

Purpose

Antimicrobial

Use

• Provide Hand sanitizing when soap and water are not available.
• Helps to kill or reduce harmful bacteria and germs.
• Recommended for repeated use.

Warnings

For external use only

When using this product

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

Stop use and ask a doctor if

If irritation or rash appears and lasts.

Keep out of reach of children

Keep out of reach of children 2 years of age or younger.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

• Rub product into hands and allow to dry
• Use as part of your daily cleansing routine
• No rinsing required

Other information

• Do not freeze
• Store at a room temperature

Inactive ingredients

aloe vera leaf extract, glucomannan 90% (Konjac), propylene glycol, purified water.

Package Label - Principal Display Panel

Sanibelle Hydrating Hand Sanitizer

50 Single-Use Vials per 1mL ea

SANIBELLE HAND SANITIZER 50 SINGLE USE VIALS X 1ML EA 
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70302-073
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 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
KONJAC MANNAN (UNII: 36W3E5TAMG)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70302-073-50	50 in 1 CARTON	07/01/2020
1		1 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/01/2020

Labeler - Unipharma, LLC (079524332)

Establishment
Name	Address	ID/FEI	Business Operations
Unipharma, LLC		079524332	manufacture(70302-073)

Revised: 6/2020

Document Id: a87510bd-d82c-5e20-e053-2995a90a17bd

34390-5

Set id: a8760d26-3892-ddd9-e053-2a95a90a2924

Version: 1

Effective Time: 20200619