Label: HANNA HAND SANITIZER GEL- 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 September 3, 2020

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

  • ACTIVE INGREDIENT

    alcohol

  • INACTIVE INGREDIENT

    Water, Glycerin, Carbomer, Triethanolamine, Fragrance, Camellia Sinensis Leaf Extract, Butylene Glycol, Aloe Barbadensis Leaf Extract, Portulaca Oleracea Extract, Centella Asiatica Extract, Pinus Densiflora Extract, CI 19140, CI 42090

  • PURPOSE

    Sterilization of hands and skin

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF THE CHILDREN

  • INDICATIONS & USAGE

    Apply an appropriate amount on your hands and rub well to dry.

  • WARNINGS

    1. Do not use on the following body parts. A wide range of body parts and damaged skin around the eyes and
    ears, in the oral cavity (may have irritating effects)
    2. If the following symptoms appear, stop using them immediately and consult a doctor or pharmacist.
    1) Hypersensitivity symptoms such as rash, erythema, itching, and edema
    2) Skin irritation symptoms
    3. Other precautions
    1) For external use only (do not underwear).
    2) Be careful not to get into your eyes, and if so, rinse well with clean water and consult a doctor or pharmacist.
    3) Be careful not to inhale the vapor when using it extensively or for a long period of time (irritation to the
    mucous membranes, headaches, etc. may occur if ethanol vapor is consumed in large quantities or repeatedly).
    4) If repeated use on the same site, be careful as the skin may become rough due to degreasing.
    5) Do not use sealed bandages, cast bandages, packs, etc., as irritation may occur.
    6) Do not use this medicine for anal or vaginal compresses as it may cause irritation or chemical burns.
    7) Do not use for any other purpose.
    4. Precautions for storage
    1) Avoid shading and keep in shading.
    2) Keep it out of reach of children, and if a child swallows it, go to the hospital right away.
    3) After use, close the product completely with a lid to prevent the product from drying out or entering foreign
    Objects.

  • DOSAGE & ADMINISTRATION

    for external use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    HANNA HAND SANITIZER GEL 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71193-101
    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
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PURSLANE (UNII: M6S840WXG5)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PINUS DENSIFLORA BARK (UNII: U68X322T49)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    WATER (UNII: 059QF0KO0R)  
    D&C BLUE NO. 4 (UNII: 0KSY80VYS3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71193-101-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product09/03/2020
    2NDC:71193-101-02300 mL in 1 BOTTLE; Type 0: Not a Combination Product09/03/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/03/2020
    Labeler - Rainbow Beauty Cosmetic Co., Ltd. (695684820)
    Registrant - Rainbow Beauty Cosmetic Co., Ltd. (695684820)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rainbow Beauty Cosmetic Co., Ltd.695684820manufacture(71193-101) , label(71193-101)