Label: AQUAGEL ADVANCED FORMULA HAND SANITIZER- alcohol gel

  • Category: HUMAN OTC DRUG LABEL

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 September 17, 2020

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  • Active Ingredient(s)

    Ethyl 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

    water, aloe extract, Carbomer, Fragrance,glycerin, Triethanolamine

  • Package Label - Principal Display Panel

    20L NDC:79996-050-07

    f

    1L NDC:79996-050-03

    f

    4L NDC:79996-050-02

    j

    52 mL NDC:79996-050-04

    l

    170 mL NDC:79996-050-01

    170

    50 Gallon NDC:79996-050-06 50250 Gallon NDC:79996-050-05

    j

    Back Label for NDC:79996-050-01,79996-050-02,79996-050-03,79996-050-04,79996-050-05,79996-050-06,79996-050-07

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    ,

  • INGREDIENTS AND APPEARANCE
    AQUAGEL ADVANCED FORMULA HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79996-050
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE (UNII: V5VD430YW9)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER 934 (UNII: Z135WT9208)  
    TRIETHANOLAMINE HYDRIODIDE (UNII: DT98IT03JK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79996-050-01170 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/30/2020
    2NDC:79996-050-024000 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/30/2020
    3NDC:79996-050-031000 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/30/2020
    4NDC:79996-050-0452 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/30/2020
    5NDC:79996-050-05946300 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/30/2020
    6NDC:79996-050-06189200 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/30/2020
    7NDC:79996-050-0720000 mL in 1 BOTTLE, DISPENSING; 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 - EPOXEMEX, S.A. de C.V. (814573127)
    Registrant - EPOXEMEX, S.A. de C.V. (814573127)
    Establishment
    NameAddressID/FEIBusiness Operations
    EPOXEMEX, S.A. de C.V.814573127manufacture(79996-050)
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