Label: PURESPA HAND SANITIZER DANDELION AND FIG- alcohol spray

  • NDC Code(s): 73025-054-60
  • Packager: Shalom International Corp
  • 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 16, 2020

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

  • Drug Facts

  • Active Ingredients

    Alcohol Denat. 60%

    Purpose

    Antibacterial

  • Uses

    • Hand sanitizer to help reduce bacteria on the skin that could cause disease. • Recommended for repeated use.

  • Warnings

    • Flamable. Keep away from fire or flame.
    • For external use only.

    When using this product

    do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

    Stop use & ask a doctor

    if irritation or rash appears & lasts.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Apply enough product to thoroughly cover hands.
    • Rub hands together briskly until dry.
  • Other Information

    • Do not store above 110°F (43°C).
    • May discolor certain fabrics or surfaces.
  • Inactive Ingredients

    • Water / Aqua, PEG-40 Hydrogenated Castor Oil, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, DMDM Hydantoin, Fragrance (Parfum), Sodium Hydroxide, Tocopheryl Acetate, D & C Red 33, FD & C Blue 1
  • Questions?

    • Call 212-391-6970
  • Package Labeling:

    Label11

  • INGREDIENTS AND APPEARANCE
    PURESPA HAND SANITIZER DANDELION AND FIG 
    alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73025-054
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.6 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73025-054-6060 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/01/2020
    Labeler - Shalom International Corp (001384825)