Label: HYDRA C3 TRIPLE RESET- witch hazel cream

  • Category: HUMAN OTC DRUG LABEL

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 March 22, 2017

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  • ACTIVE INGREDIENT

    Active ingredients: WITCH HAZEL 5.0%

  • INACTIVE INGREDIENT

    Inactive ingredients: Aqua (WATER), Glycerin (and) Glyceryl Polyacrylate, Bifida Ferment Lysate, Glycerin, Propylene Glycol, Phenoxyethanol, Carbomer, Triethanolamine, Olive Glycerides, Ceramide 3, Fragrance, Mica, CI 77891, Silica, Ethylhexylglycerin, CI 77491, Tin oxide

  • PURPOSE

    Purpose: Skin nourishing and strengthening

  • WARNINGS

    Warnings: For external use only Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • INDICATIONS & USAGE

    Indications & Usage: Apply morning and night

  • DOSAGE & ADMINISTRATION

    Dosage & Administration: Apply morning and night to face and neck after serum and ampoule

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    HYDRA C3 TRIPLE RESET 
    witch hazel cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71276-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL3.0 g  in 60 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71276-100-021 in 1 CARTON03/02/2017
    1NDC:71276-100-0160 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/02/2017
    Labeler - ULAB (688976692)
    Registrant - ULAB (688976692)
    Establishment
    NameAddressID/FEIBusiness Operations
    ULAB688976692relabel(71276-100)
    Establishment
    NameAddressID/FEIBusiness Operations
    U-LAB Switzerland AG485958743manufacture(71276-100)
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