SANITIZING HAND MIST - UNSCENTED- ethyl alcohol spray 
SANITIZING HAND GEL - UNSCENTED- ethyl alcohol gel 
SANITIZING HAND GEL - LEMONGRASS- ethyl alcohol gel 
SANITIZING HAND MIST - PEPPERMINT EUCALYPTUS- ethyl alcohol spray 
SANITIZING HAND MIST - LEMONGRASS- ethyl alcohol spray 
SANITIZING HAND GEL - PEPPERMINT EUCALYPTUS- ethyl alcohol gel 
Alkaline Corporation

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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ALO Brands Hand Sanitizer

Active Ingredients

Ethyl Alcohol 70%

Purpose

Antiseptic

Uses

For handwashing to decrease bacteria on the skin

Warnings

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

When using this product

Do not use in eyes. In case of contact with eyes, rinse with water.

Stop use and ask a doctor if

irritation and redness develop and persist.

Keep out of reach of children.

If swallowed, get medical help promptly.

Directions

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

Other information

Store under 105°F

Inactive Ingredients

NDC 80588-010:

Water, Glycerine, Aloe Barbadensis Leaf

NDC 80588-011:

Water, Glycerine, Aloe Barbadensis Leaf, Eucalyptus Radiata Flower/Leaf/Stem Oil, Piper Mentha Piperita (Peppermint) Oil

NDC 80588-012:

Water, Glycerine, Aloe Barbadensis Leaf, Cymbopogon Schoenanthus (Lemongrass) Oil

NDC 80588-020:

Water, Glycerine, Rapidgel EZ, Aloe Barbadensis Leaf

NDC 80588-011:

Water, Glycerine, Rapidgel EZ, Aloe Barbadensis Leaf, Eucalyptus Radiata Flower/Leaf/Stem Oil, Piper Mentha Piperita (Peppermint) Oil

NDC 80588-012:

Water, Glycerine, Rapidgel EZ, Aloe Barbadensis Leaf, Cymbopogon Schoenanthus (Lemongrass) Oil

Sanitizing Hand Mist - Unscented + Aloe: NDC 80588-010-02

NDC 80588-010-02

Sanitizing Hand Mist - Unscented + Aloe: NDC 80588-010-08

NDC 80588-010-08

Sanitizing Hand Mist - Peppermint Eucalyptus + Aloe: NDC 80588-011-02

NDC 80588-011-02

Sanitizing Hand Mist - Peppermint Eucalyptus + Aloe: NDC 80588-011-08

NDC 80588-011-08

Sanitizing Hand Mist - Lemongrass + Aloe: NDC 80588-012-02

NDC 80588-012-02

Sanitizing Hand Mist - Lemongrass + Aloe: NDC 80588-012-08

NDC 80588-012-08

Sanitizing Hand Gel - Unscented + Aloe: NDC 80588-020-08

NDC 80588-020-08

Sanitizing Hand Gel - Unscented + Aloe: NDC 80588-020-32

NDC 80588-020-32

Sanitizing Hand Gel - Peppermint Eucalyptus + Aloe: NDC 80588-021-08

NDC 80588-021-08

Sanitizing Hand Gel - Peppermint Eucalyptus + Aloe: NDC 80588-021-32

NDC 80588-021-32

Sanitizing Hand Gel - Lemongrass + Aloe: NDC 80588-022-08

NDC 80588-022-08

Sanitizing Hand Gel - Lemongrass + Aloe: NDC 80588-022-32

NDC 80588-022-32

SANITIZING HAND MIST - UNSCENTED 
ethyl alcohol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80588-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALOE (UNII: V5VD430YW9)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80588-010-0259 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/09/2022
2NDC:80588-010-08236 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/09/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/09/2022
SANITIZING HAND GEL - UNSCENTED 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80588-020
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE (UNII: V5VD430YW9)  
ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80588-020-08236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/09/2022
2NDC:80588-020-32900 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product06/09/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/09/2022
SANITIZING HAND GEL - LEMONGRASS 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80588-022
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
EAST INDIAN LEMONGRASS OIL (UNII: UP0M8M3VZW)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE (UNII: V5VD430YW9)  
ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80588-022-08236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/09/2022
2NDC:80588-022-32900 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product06/09/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/09/2022
SANITIZING HAND MIST - PEPPERMINT EUCALYPTUS 
ethyl alcohol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80588-011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE (UNII: V5VD430YW9)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80588-011-0259 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/09/2022
2NDC:80588-011-08236 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/09/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/09/2022
SANITIZING HAND MIST - LEMONGRASS 
ethyl alcohol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80588-012
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE (UNII: V5VD430YW9)  
EAST INDIAN LEMONGRASS OIL (UNII: UP0M8M3VZW)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80588-012-0259 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/09/2022
2NDC:80588-012-08236 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/09/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/09/2022
SANITIZING HAND GEL - PEPPERMINT EUCALYPTUS 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80588-021
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
PEPPERMINT OIL (UNII: AV092KU4JH)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE (UNII: V5VD430YW9)  
ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80588-021-08236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/09/2022
2NDC:80588-021-32900 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product06/09/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/09/2022
Labeler - Alkaline Corporation (790098318)
Establishment
NameAddressID/FEIBusiness Operations
Alkaline Corporation790098318manufacture(80588-010, 80588-011, 80588-012, 80588-020, 80588-021, 80588-022) , pack(80588-010, 80588-011, 80588-012, 80588-020, 80588-021, 80588-022) , label(80588-010, 80588-011, 80588-012, 80588-020, 80588-021, 80588-022)

Revised: 6/2022
Document Id: e1054a74-1479-092f-e053-2a95a90a092a
Set id: e1054a74-1478-092f-e053-2a95a90a092a
Version: 1
Effective Time: 20220609
 
Alkaline Corporation