Label: TEEM HOGAR- 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 August 13, 2020

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

  • ACTIVE INGREDIENT

    Alcohol 68% v/v. Purpose: Antiseptic

  • PURPOSE

    Antiseptic, Hand Sanitizer

  • USE IN SPECIFIC POPULATIONS

    Hand Sanitizer to help reduce bacteria that potentially can use 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 swallwed, get medical help or contact o Poison Control Center righ 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 reach of children. If sqallowed, get medical help or contact a Poison Control Center right away.

  • OTHER SAFETY INFORMATION

    Store between 15-30C (59-86F)

    Avoid freezing and excessive heat above 40C (104F)

  • INACTIVE INGREDIENT

    Water USP, glycerin, triethalonamine and carbomer.

  • DOSAGE & ADMINISTRATION

    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.

  • INDICATIONS & USAGE

    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.

  • PRINCIPAL DISPLAY PANEL

    1000000 mL NDC: 79004-005-01 PDP 1000000

  • INGREDIENTS AND APPEARANCE
    TEEM HOGAR 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79004-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL68 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 30.45 mL  in 100 mL
    CARBOMER 1342 (UNII: 809Y72KV36) 0.4 mL  in 100 mL
    TRIETHANOLAMINE HYDRIODIDE (UNII: DT98IT03JK) 0.4 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 0.75 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79004-005-011000000 mL in 1 CONTAINER; Type 0: Not a Combination Product07/17/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/17/2020
    Labeler - Saniklyn, S. de R.L. de M.I (816628069)
    Establishment
    NameAddressID/FEIBusiness Operations
    Saniklyn, S. de R.L. de M.I.816628069manufacture(79004-005) , label(79004-005) , pack(79004-005)