Label: AQUA GEL- alcohol 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 26, 2021

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  • 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

    polyacrylic acid (Carbomer), triethanolamine (Trolamine), water

  • 20 L NDC: 77739-001-01

    20 L NDC: 77739-001-01 AQUAGEL_01

  • 3780 mL NDC: 77739-001-02

    AQUAGEL_023780 mL NDC: 77739-001-02

  • 1L NDC: 77739-001-04

    AQUAGEL_041L NDC: 77739-001-04

  • 500 mL NDC: 77739-001-05

    AQUAGEL_05500 mL NDC: 77739-001-05

  • 250 mL NDC: 77739-001-06

    AQUAGEL_06250 mL NDC: 77739-001-06

  • 5L NDC: 77739-001-12

    5L NDC: 77739-001-12

    AQUAGEL_07P

  • 125 mL NDC: 77739-001-08

    AQUAGEL_08125 mL NDC: 77739-001-08

  • 60 mL NDC: 77739-001-09

    AQUAGEL_0960 mL NDC: 77739-001-09

  • 200L NDC: 77739-001-10

    SAQUAGEL_10200L NDC: 77739-001-10

  • 1000L 77739-001-11

    1000L 77739-001-11 AQUAGEL_11

  • INGREDIENTS AND APPEARANCE
    AQUA GEL 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77739-001
    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
    POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F) 0.03 mL  in 100 mL
    TROLAMINE (UNII: 9O3K93S3TK) 1 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 28.97 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77739-001-0120000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/02/2020
    2NDC:77739-001-023780 mL in 1 BOTTLE; Type 0: Not a Combination Product06/02/2020
    3NDC:77739-001-041000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/02/2020
    4NDC:77739-001-05500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/02/2020
    5NDC:77739-001-06250 mL in 1 BOTTLE; Type 0: Not a Combination Product06/02/2020
    6NDC:77739-001-08125 mL in 1 BOTTLE; Type 0: Not a Combination Product06/02/2020
    7NDC:77739-001-0960 mL in 1 BOTTLE; Type 0: Not a Combination Product06/02/2020
    8NDC:77739-001-10200000 mL in 1 CONTAINER; Type 0: Not a Combination Product06/02/2020
    9NDC:77739-001-111000000 mL in 1 CONTAINER; Type 0: Not a Combination Product06/02/2020
    10NDC:77739-001-125000 mL in 1 BOTTLE; Type 0: Not a Combination Product01/28/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/02/2020
    Labeler - AD MEDIOS, S.A. DE C.V. (814581377)
    Registrant - AD MEDIOS, S.A. DE C.V. (814581377)
    Establishment
    NameAddressID/FEIBusiness Operations
    AD MEDIOS S.A. DE C.V.814581377manufacture(77739-001)
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