Label: NRL PURE DAILY HAND SANITIZER- 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 April 8, 2020

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

  • ACTIVE INGREDIENT

    Active ingredients: ALCOHOL 62.0%

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Water, Glycerin, Carbomer, Triethanolamine

  • PURPOSE

    Purpose: SANITIZER

  • WARNINGS

    Warnings:

    1. Do not use on the following body parts. (Eyes and ears, inside the mouth, wide body parts, and damaged skin)
    2. If the following symptoms appear, immediately stop using and consult a physician or pharmacist. (Hypersensitivity such as rash, erythema, itchiness, and edema / Skin irritation)
    3. Only use externally (do not intake)
    4. When using on a wide area or for a long period, be careful about inhaling vapor. (Massive or repeated intake of ethanol vapor can cause irritation of the mucous membrane or headache, limited to products containing ethanol.)
    5. Repeated use on the same part can cause roughening of the skin by removing oiliness.
    6. Do not use on seal rod, plaster cast, and pack as doing so can cause irritation.
    7. Do not use this product like a pack for the anus or vagina as doing so can cause irritation or chemical burn.
    8. Only use for intended purposes.
    9. Avoid firearms and protect from the light.
    10. Keep away from children. If swallowed by a child, visit a hospital immediately.
    11. Storing this product in a different bottle can lead to accidents or degradation from misuse. Keep the product in its original bottle and firmly close the bottle.
    12. Do not use expired sanitary aids.

  • KEEP OUT OF REACH OF CHILDREN

    Keep away from children. If swallowed by a child, visit a hospital immediately.

  • Uses

    Uses:
    ■ Skin moisturizing
    ■ Sterilization of harmful bacteria
    ■ Disinfection of hands and skin

  • Directions

    Directions:

    ■ Take adequate amount onto a palm.
    ■ Rub the two palms together.
    ■ Lock fingers together and rub between fingers and fingernails.
    ■ Wrap your fingers with the palm and rub to dry them.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of bottle

  • INGREDIENTS AND APPEARANCE
    NRL PURE DAILY HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74083-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL43.4 g  in 70 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74083-010-0170 mL in 1 BOTTLE; Type 0: Not a Combination Product03/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/01/2020
    Labeler - Gpompous Trading Co., Ltd. (695886541)
    Registrant - Gpompous Trading Co., Ltd. (695886541)
    Establishment
    NameAddressID/FEIBusiness Operations
    Gpompous Trading Co., Ltd.695886541manufacture(74083-010)