HAND SANITIZER- isopropyl alcohol gel 
Mesa Lavender Farms

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Gel Sanitizer

Isopropyl alcohol 70% v/v...................... Antiseptic

Active ingredient[s] Purpose

Isopropyl alcohol 70% v/v...................... Antiseptic

Use[s]

Hand sanitizer to help reduce bacteria that potentially can cause disease.

Warnings

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

Do not use

in children less than 2 months of age

on open skin wounds

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.

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.

Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

Store below 110°F (43°C)

May discolor certain fabrics or surfaces

Inactive ingredients

water, glycerin, carbomer, triethanolamine, fragrance, color additive

66 ml NDC: 80311-252-21

252 Front

252 Back

66 ml NDC: 80311-000-21

000 Front

000 Back

HAND SANITIZER 
isopropyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80311-252
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.705 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 (UNII: WZB9127XOA)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GLYCERIN (UNII: PDC6A3C0OX)  
NONOXYNOL-9 (UNII: 48Q180SH9T)  
Product Characteristics
ColorpurpleScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80311-252-2166 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/07/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/07/2020
HAND SANITIZER 
isopropyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80311-000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.705 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
METHYL IONONES (UNII: EL78BGX1LO)  
WATER (UNII: 059QF0KO0R)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERIN (UNII: PDC6A3C0OX)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
NONOXYNOL-9 (UNII: 48Q180SH9T)  
Product Characteristics
Colorwhite (clear gel) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80311-000-2166 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/07/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/07/2020
Labeler - Mesa Lavender Farms (035642809)
Registrant - Mesa Lavender Farms (035642809)
Establishment
NameAddressID/FEIBusiness Operations
Mesa Lavender Farms035642809manufacture(80311-252, 80311-000)

Revised: 11/2020
Document Id: b543edbd-c9d1-76bd-e053-2a95a90a5987
Set id: ad3045b9-9846-9149-e053-2995a90a66cb
Version: 4
Effective Time: 20201129
 
Mesa Lavender Farms