HAND SANITIZER- alcohol gel 
Bell Food & Beverage 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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Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic

Purpose

Antiseptic

Use[s]

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

Aloe Barbadensis Leaf Juice, Caprylyl Glycol, CI-42090, Ethyl Macadamiate, Eucalyptus Globulus Leaf Oil, Glycerin, Menthol, Polysorbate 80, Propylene Glycol, Safflower Glyceride, Tocopheryl Acetate, Water, 1,2-Hexanediol

Package Label - Principal Display Panel

500ml label500 mL NDC: 73806-0004-1

1892 mL NDC: 73806-0004-2 1892mL Label

3785mL NDC: 73806-0004-3

3785 mL Label

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73806-0004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ETHYL MACADAMIATE (UNII: ANA2NCS6V1)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73806-0004-1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/01/2020
2NDC:73806-0004-21892 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/01/2020
3NDC:73806-0004-33785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A11/20/2020
Labeler - Bell Food & Beverage Inc. (081550987)
Establishment
NameAddressID/FEIBusiness Operations
Bell Food & Beverage Inc.081550987manufacture(73806-0004)

Revised: 11/2020
Document Id: b48ec4e3-cea5-5467-e053-2995a90aa950
Set id: b48ec9d5-6641-c01e-e053-2a95a90a5afd
Version: 1
Effective Time: 20201120
 
Bell Food & Beverage Inc.