Label: 390 FIT FOR HEALTH 70 ALCOHOL TOPICAL SOLUTION- 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 11, 2020

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  • Drug Facts

  • Active ingredient(s)

    Ethanol 70%

    Purpose.

    Antibacterial.

  • Use(s)

    Hand Sanitizer.

  • Warnings

    Highly flammable liquid and vapor.
    Keep away from heat/sparks/open flames/hot surfaces

    Do not swallow,

    if swallows get medical help and contact the nearest poison centre.

    When using this product

    keep out of eyes, in case of contact with eyes, rinse with water.

    Stop use and ask a doctor

    if irritation and redness develops and persists.

    Keep out of reach of chilldren

    Keep out of sight and reach of children.

  • Directions:

    Wet hand thoroughly with product and allow to dry without wiping.

  • Other information:

    Store between 15-30 ºC (59-86 ºF) and out of direct sunlight, do not mix with other products, Dispose of contents/container in accordance with local/regional regulations.

  • Inactive Ingredients:

    Glycerin, Polyethylene Oxide, Polygel HG, Triethanolamine, Ethanol, Peroxide, Water (q.s).

  • Package Labeling:

    Bottle

  • INGREDIENTS AND APPEARANCE
    390 FIT FOR HEALTH 70 ALCOHOL TOPICAL SOLUTION 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79676-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79676-000-013780 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package07/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/01/2020
    Labeler - Tangible Nous, S.A. de C.V. (814498135)
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