Label: PYROXY GEL-70 BASE POLY CLEAR- 70% gel hand sanitizer - base poly clear gel

  • 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 January 30, 2022

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  • SPL UNCLASSIFIED SECTION

    The hand sanitizer is manufactured in response to the COVID-19 pandemic

    1. Alcohol (ethanol) (70%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
    2. Glycerol (2.01% v/v).
    3. Carbomber (1.33% v/v).
    4. Deionized or reverse osmosis water
  • Active Ingredient(s)

    Alcohol 70% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • 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

    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.

  • STOP USE

    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

    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 between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    glycerin, purified water, carbomer, triethanolamine

  • Package Label - Principal Display Panel

    Front 18927.05 mL NDC: 78517-711-95

    Back 18927.05 mL NDC: 78517-711-95

    Front 1249185.9 mL NDC: 78517-711-33Back 1249185.9 mL NDC: 78517-711-33

    Front 1040988.2 mL NDC: 78517-711-27Back 1040988.2 mL NDC: 78517-711-27

    Front 208197.65 mL NDC: 78517-711-55Back ​208197.65 mL NDC: 78517-711-55

    Front 25362259 mL NDC: 78517-711-67Back 25362259 mL NDC: 78517-711-67

    Front 3785.41 mL NDC: 78517-711-01Back 3785.41 mL NDC: 78517-711-01

    Front 250 mL NDC: 78517-711-92Back ​250 mL NDC: 78517-711-92

    Front 1000 ml NDC: 78517-711-91Back ​1000 ml NDC: 78517-711-91

  • INGREDIENTS AND APPEARANCE
    PYROXY GEL-70 BASE POLY CLEAR 
    70% gel hand sanitizer - base poly clear gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78517-711
    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
    CARBOMER 1342 (UNII: 809Y72KV36) 0.4 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 0.3 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 29.05 mL  in 100 mL
    CUPRIC BIS(TRIETHANOLAMINE) (UNII: YBM44X0B6H) 0.25 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78517-711-6725362259 mL in 1 TANK; Type 0: Not a Combination Product03/30/2020
    2NDC:78517-711-331249185.9 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product03/30/2020
    3NDC:78517-711-271040988.2 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product03/30/2020
    4NDC:78517-711-55208197.65 mL in 1 DRUM; Type 0: Not a Combination Product03/30/2020
    5NDC:78517-711-013785.41 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/30/2020
    6NDC:78517-711-911000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    7NDC:78517-711-92250 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    8NDC:78517-711-9518927.05 mL in 1 PAIL; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - Pyrock Chemical (117537129)
    Establishment
    NameAddressID/FEIBusiness Operations
    Reflow Supply Chain Solutions LLC117537129manufacture(78517-711)
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