Label: GRAND INNOVATIONS 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 May 5, 2020

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  • SPL UNCLASSIFIED SECTION

    NA

  • Active Ingredient(s)

    Ethyl Alcohol 70% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    Hand Sanitizer to help decrease bacteria on skin. when water, soap& towel are not available. recommended for repeated use.

  • Warnings

    For external use only: hands. Flammable. Keep away from fire or flame

  • Do not use

    • Do not apply around eyes.Do not use in ears&mouth
  • WHEN USING

    When using this product avoid contact with eyes, In case of contact flush eyes with water.

    Stop use and ask a doctor if redness or irritation develop and persist for more than 72 hours.

    Keep out of reach of children. Children must be supervised in use of this product.

  • STOP USE


    Stop use and ask a doctor if redness or irritation develop and persist for more than 72 hours

  • KEEP OUT OF REACH OF CHILDREN


    Keep out of reach of children. Children must be supervised in use of this product.

  • Directions

    wet hands thoroughly with product and allow to dry without wiping for children under 6, use only under adult supervision,
    not recommended for infants

  • Other information


    store between 59-86F (15~30C) ,may discolor some fabrics， harmful to wood finishes and plastics

  • Inactive ingredients

    water, propylene glycol,glycerin, carbomer.triethanolamine

  • Package Label - Principal Display Panel

    50 mL NDC: 74765-011-01 50ml label

    150 mL NDC: 74765-011-02

    236 mL NDC: 74765-011-03

    500 mL NDC: 74765-011-04

  • INGREDIENTS AND APPEARANCE
    GRAND INNOVATIONS HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74765-011
    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
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER 980 (UNII: 4Q93RCW27E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74765-011-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    2NDC:74765-011-02150 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    3NDC:74765-011-03236 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    4NDC:74765-011-04500 mL in 1 BOTTLE; 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 - Zhejiang Yiwu Limei Cosmetics Co., Ltd (679892245)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Yiwu Limei Cosmetics Co., Ltd679892245manufacture(74765-011)
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