Label: OLIKA ULTRA HYDRATING HAND SANITIZER, UNSTOPPABLE- 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 May 7, 2022

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  • ACTIVE INGREDIENT

    Ethyl Alcohol 65% v/v. Purpose: Antiseptic

  • PURPOSE

    Antiseptic, Hand Sanitizer

  • INDICATIONS & USAGE

    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.

  • 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.

  • STORAGE AND HANDLING

    Store between 15-30C (59-86F)
    Avoid freezing and excessive heat above 40C (104F)

  • INACTIVE INGREDIENT

    water, glycerin, fragrance, aloe vera (aloe barbadensis) leaf juice, hyaluronic acid, denatonium benzoate,

  • PRINCIPAL DISPLAY PANEL

    90 ml pouch20ml90 ML NDC# 73517-941-03

    20 ML NDC# 73517-941-02

  • INGREDIENTS AND APPEARANCE
    OLIKA ULTRA HYDRATING HAND SANITIZER, UNSTOPPABLE 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73517-941
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    WATER (UNII: 059QF0KO0R)  
    FRAGRANCE 13576 (UNII: 5EM498GW35)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73517-941-0220 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product05/06/2022
    2NDC:73517-941-0390 mL in 1 POUCH; Type 0: Not a Combination Product05/06/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/06/2022
    Labeler - Amyris, Inc (185930182)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taizhou Jingshang Cosmetics Technology Co., Ltd.550819554manufacture(73517-941)
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