Label: 503BOU RX FRESH PURE HAND- alcohol gel

  • NDC Code(s): 73864-010-01, 73864-010-02, 73864-010-03, 73864-010-04, view more
    73864-010-05
  • Packager: Salty Family Group Co., Ltd.
  • 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 1, 2020

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

  • ACTIVE INGREDIENT

    Active ingredients: ALCOHOL 70.00 wt%

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Carbomer, Butylene Glycol, Triethanolamine, Polysorbate 60, Isopropyl Myristate,
    Fragrance, Water

  • PURPOSE

    Purpose: SANITIZER

  • WARNINGS

    Warnings (500mL Bottle, 1.5mL*30pcs, 1.5mL*100pcs)

    For external use only. Avoid contact with eyes.

    Discontinue use if signs of irritation or rashes appear.

    Keep out of reach of children.

    Warnings (70mL Tube)

    For external use only.
    Avoid contact with eyes.
    Discontinue use if signs of irritation or rashes appear.
    Replace the cap after use.
    Keep out of reach of children.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • Uses

    Uses:
    ■ Hand sanitizer to decrease the bacteria on the skin.
    ■ Recommended for repeated use.

  • Directions

    Directions:
    ■ Rub a dime sized drop into hands.

  • PACKAGE LABEL - 503BOU RX FRESH PURE HAND GEL 500mL Bottle Pump

    Image of bottle

  • PACKAGE LABEL - 503BOU RX FRESH PURE HAND GEL 70mL Tube

    Image of tube

  • PACKAGE LABEL - 503BOU RX FRESH PURE HAND GEL 1.2mL*30pcs

    Image of carton

  • PACKAGE LABEL - 503BOU RX FRESH PURE HAND GEL 1.2mL*100pcs

    Image of carton

  • INGREDIENTS AND APPEARANCE
    503BOU RX FRESH PURE HAND 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73864-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Polysorbate 60 (UNII: CAL22UVI4M)  
    Isopropyl Myristate (UNII: 0RE8K4LNJS)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73864-010-01500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/01/2020
    2NDC:73864-010-0270 mL in 1 TUBE; Type 0: Not a Combination Product03/01/2020
    3NDC:73864-010-0430 in 1 CARTON03/01/2020
    3NDC:73864-010-031.2 mL in 1 PACKET; Type 0: Not a Combination Product
    4NDC:73864-010-05100 in 1 CARTON03/01/2020
    4NDC:73864-010-031.2 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/01/2020
    Labeler - Salty Family Group Co., Ltd. (689057520)
    Registrant - Salty Family Group Co., Ltd. (689057520)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ester Co., Ltd.688425766manufacture(73864-010)