NOVAGEL WIPES- sanitizing wipes liquid 
HYDRA PEARL WIPE- sanitizing wipe liquid 
NOVAGEL- antiseptic spray spray 
Nanova Biomaterials 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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Principle Display Panel

Liquid Sanitizer Spray

Active Ingredient

Ethyl Alcohol 80% v/v Antiseptic

Purpose Section

Use - To decrease bacteria on skin

Keep out of the reach of children

Keep out of reach of children

Use - To decrease bacteria on skin

Use - To decrease bacteria on skin

Warnings

Warnings

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

Dosage

Active Ingredient

Ethyl Alcohol 80% v/v

Inactive Ingredient Section

Inactive Ingredients

Glycerin, Water

Hydra Pearl Wipes

Hydra Pearl Wipe Label

NovaGel Wipes Label

NovaGel Wipes Label

NOVAGEL WIPES 
sanitizing wipes liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80947-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL490 mL  in 700 mL
Inactive Ingredients
Ingredient NameStrength
ALOE (UNII: V5VD430YW9) 0.35 mL  in 700 mL
WATER (UNII: 059QF0KO0R) 200.2 mL  in 700 mL
GLYCERIN (UNII: PDC6A3C0OX) 9.45 mL  in 700 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80947-003-01700 mL in 1 CANISTER; Type 0: Not a Combination Product03/17/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/17/2021
HYDRA PEARL WIPE 
sanitizing wipe liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80947-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL490 mL  in 700 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 9.45 mL  in 700 mL
ALOE (UNII: V5VD430YW9) 0.35 mL  in 700 mL
WATER (UNII: 059QF0KO0R) 200.2 mL  in 700 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80947-002-01700 mL in 1 CANISTER; Type 0: Not a Combination Product03/17/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/17/2021
NOVAGEL 
antiseptic spray spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80947-001
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) 18.55 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80947-001-013785 mL in 1 BOTTLE; Type 0: Not a Combination Product10/28/2020
2NDC:80947-001-02946 mL in 1 BOTTLE; Type 0: Not a Combination Product10/28/2020
3NDC:80947-001-03473 mL in 1 BOTTLE; Type 0: Not a Combination Product11/10/2020
4NDC:80947-001-04908499 mL in 1 CONTAINER; Type 0: Not a Combination Product01/20/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/28/2020
Labeler - Nanova Biomaterials Inc (006084093)

Revised: 3/2021
Document Id: bd08be3a-3dd0-153b-e053-2995a90ac72a
Set id: b2c2967a-0c17-5dd1-e053-2995a90afae3
Version: 4
Effective Time: 20210308
 
Nanova Biomaterials Inc