Label: HYDRAHEAL FOOT CREAM- glycerin and vitamin e foot cream liniment

  • NDC Code(s): 83872-017-01
  • Packager: Shenzhen XiaoMai Manufacturing Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated February 6, 2024

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

  • Active ingredients



    Tea Tree Oil - 5%
    Honey - 3%
    Urea - 10%

  • PURPOSE


    Designed to provide deep hydration and soothing relief, it helps maintain soft and moisturized foot skin while alleviating dryness, roughness, and foot fatigue.

  • Uses


    Apply the foot cream evenly onto clean feet, gently massage with fingertips, paying special attention to dry or rough areas. It is recommended for daily use, especially before bedtime, to maintain soft and moisturized foot skin and alleviate dryness, roughness, and foot fatigue.

  • Warning

    For external use only

  • not use


    On damaged or broken skin.

  • When using this product


    keep out of eyes. Rinse with water to remove.

  • Stop use and ask a doctor


    Discontinue use immediately if you experience severe discomfort and
    seek medical attention promptly.

  • Keep out of reach of children.


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

  • Directions


    Apply the foot cream evenly onto clean feet, gently massage with fingertips, paying special attention to dry or rough areas. It is recommended for daily use, especially before bedtime, to maintain soft and moisturized foot skin and alleviate dryness, roughness, and foot fatigue.

  • Inactive ingredients


    Water - 66.5%
    Glycerin - 10%
    Glyceryl Stearate - 0.5%
    Propylene Glycol - 2%
    Cetearyl Alcohol - 2%
    Vitamin E - 0.5%
    Pro-Vitamin B5 - 0.5%

  • Other information


    Store in a cool and dry place to maintain product quality. Avoid exposure to direct sunlight and high temperatures. Ensure the container is kept tightly sealed.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    HYDRAHEAL FOOT CREAM 
    glycerin and vitamin e foot cream liniment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83872-017
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TEA TREE OIL (UNII: VIF565UC2G) (TEA TREE OIL - UNII:VIF565UC2G) TEA TREE OIL5 g  in 100 mL
    HONEY (UNII: Y9H1V576FH) (HONEY - UNII:Y9H1V576FH) HONEY3 g  in 100 mL
    1,3-BIS(BENZOTHIAZOL-2-YLTHIOMETHYL)UREA (UNII: 0214C2T14J) (HONEY - UNII:Y9H1V576FH) 1,3-BIS(BENZOTHIAZOL-2-YLTHIOMETHYL)UREA10 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-15 GLYCERYL STEARATE (UNII: 91245SPD5K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83872-017-0150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product02/07/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/07/2024
    Labeler - Shenzhen XiaoMai Manufacturing Co., Ltd. (712999147)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shenzhen XiaoMai Manufacturing Co., Ltd.712999147manufacture(83872-017)