HAND SANITIZER 2.0- ethyl alcohol liquid 
HAND SANITIZER- ethyl alcohol liquid 
Sustainable Community Development, L.L.C.

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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Hand Sanitizer version 2.0 submission

Active Ingredient - 80% Ethyl Alcohol

Uses: Helps reduce bacteria on the skin.

For use when soap and water are not available.

For external use only.

When using this product:

Keep out of eyes.

In case of contact with eyes, flush thoroughly with water.

Avoid contact with broken skin

Stop use and call a doctor if irritation and redness develop and persist for more than 72 hours

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

Spray directly on hands and rub in thoroughly. For children under 6, use adult supervision. Not recommended for infants.

Glycerin, Hydrogen Peroxide, Organic Lavender Essential Oil, Organic Geranium Essential Oil, Purified Water

Uses: Helps reduce bacteria on the skin. For use when soap and water are not available.

Hand Sanitizer 2.0
Hand Sanitizer 1.0

Hand Sanitizer 1.0

Hand Sanitizer 1.0

Hand Sanitizer 2.0

4.4 oz Geranium label

HAND SANITIZER 2.0 
ethyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79107-322
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
LACTIC ACID (UNII: 33X04XA5AT) 0.5 mL  in 100 mL
GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG) 0.2 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 17.525 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
LAVENDER OIL (UNII: ZBP1YXW0H8) 0.2 mL  in 100 mL
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79107-322-44130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product09/21/2020
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/21/2020
HAND SANITIZER 
ethyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79107-321
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
WATER (UNII: 059QF0KO0R) 18.12 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.13 mL  in 100 mL
LAVENDER OIL (UNII: ZBP1YXW0H8) 0.3 mL  in 100 mL
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79107-321-43130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/17/2020
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/17/2020
Labeler - Sustainable Community Development, L.L.C. (080469293)
Registrant - Sustainable Community Development, L.L.C. (080469293)
Establishment
NameAddressID/FEIBusiness Operations
Sustainable Community Development, L.L.C.080469293manufacture(79107-321, 79107-322)

Revised: 8/2020
Document Id: ad41972d-ac43-502e-e053-2a95a90a6819
Set id: ad463796-f75b-211c-e053-2a95a90a6198
Version: 4
Effective Time: 20200819
 
Sustainable Community Development, L.L.C.