Label: NOVAGEL WIPES- sanitizing wipes liquid
HYDRA PEARL WIPE- sanitizing wipe liquid
NOVAGEL- antiseptic spray spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated March 8, 2021

If you are a consumer or patient please visit this version.

  • 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

  • INGREDIENTS AND APPEARANCE
    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)