Label: ESSENTIALS HAND SANITIZER- alcohol gel

  • NDC Code(s): 76626-003-01, 76626-003-02, 76626-003-03, 76626-003-04, view more
    76626-003-05, 76626-003-06, 76626-003-07
  • Packager: MCRL Overseas Printing Inc
  • 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 April 17, 2020

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  • Active Ingredient

    Ethyl Alcohol 70%

  • Purpose

    Sanitizer

  • Uses

    • to decrease bacterias on the skin that could cause diseases. 
    • recommended for repeated use
  • Warnings

    For external use only-hands. Use only as directed. Excessive use or prolonged exposure may cause irritation to skin. Discontinue use if rash, redness or itching appears. 

    Flammable. Keep away from heat or flame.

    When using this product

    • keep out of eyes. In case of contact with eyes, immediately flush with water and call a doctor.
    • avoid contact with broken skin.

    Stop use and ask a doctor if irritation or redness develops.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    In case of accidental ingestion seek professional assistance or contact a poison control center immedietly.

  • Directions

    Put a thumb size amount in your palm and  rub hands together briskly until dry.

    Other information:

    • do not store in temperature over 118F.
    • children under the 6 years of age should be supervised while using this product.
    • may discolor certain fabrics.
  • Inactive ingredients

    Water, glycerin, propylene Glycol, carbomer, sodium hydroxide   

  • Package Label - Principal Display Panel

    label 60 mL

    Label

  • INGREDIENTS AND APPEARANCE
    ESSENTIALS HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76626-003
    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
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76626-003-0130 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/17/2020
    2NDC:76626-003-0260 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/17/2020
    3NDC:76626-003-03237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/17/2020
    4NDC:76626-003-04100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/17/2020
    5NDC:76626-003-05300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/17/2020
    6NDC:76626-003-06500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/17/2020
    7NDC:76626-003-071000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/17/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/17/2020
    Labeler - MCRL Overseas Printing Inc (257078621)
    Establishment
    NameAddressID/FEIBusiness Operations
    Huizhou Bliss Commodity Co. Ltd.417467331manufacture(76626-003)
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