SANITELLE HAND SANITIZER AROMA OF COFFEE- alcohol spray 
BENTUS LABORATORII, OOO

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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Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

Aqua, Glycerin, Propylene Glycol, Tocopherol, Aloe Barbadensis Leaf Juice, Parfum, Benzyl Benzoate

Package Label - Principal Display Panel

NDC: 80068-011-01

Distributed by: Flex Technologies, Inc, 10432 Balls Ford Rd. Suite 300, Manassas, VA 20109, USA

SANITELLE HAND SANITIZER AROMA OF COFFEE 
alcohol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80068-011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TOCOPHEROL (UNII: R0ZB2556P8)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BENZYL BENZOATE (UNII: N863NB338G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80068-011-0142 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/27/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/27/2021
Labeler - BENTUS LABORATORII, OOO (354757383)
Establishment
NameAddressID/FEIBusiness Operations
BENTUS LABORATORII, OOO354757383manufacture(80068-011)

Revised: 3/2021
Document Id: be824ff5-0d25-6e5a-e053-2a95a90a6f99
Set id: be825073-7f29-08cf-e053-2995a90a6af9
Version: 1
Effective Time: 20210327
 
BENTUS LABORATORII, OOO