Label: FOOT DETOX- zinc oxide patch

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 January 17, 2020

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  • Active Ingredients

    Zinc Oxide    8.3%

  • Purpose

    Zinc Oxide                 Skin Protectant

  • Directions

    Adults, and children 12 years of age and over, clean and dry up the area for the patch to be attached. Remove the protective cover sheet and gently apply. Leave it on at least 4 hours before removal. Children under 12 years of age, consult a doctor.

  • DOSAGE & ADMINISTRATION

    For adults, and children 12 years of age and over, use 1 patch daily before bed.

  • When Using the Product

    Do not use otherwise than directed.
    Do not stretch out the adhesive tape.
    Do not take out the contents from the patch.
    If patch is damaged, discard it right away.

  • Warning

    For External Use Only.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. if swallowed, get medical help or contact a Poison Control Center right away.

  • Do Not Use

    On wounds, damaged skin or face.
    If you are allergic to any ingredients of the product.
    With other external product at the same time.

  • Stop Use and Ask a Doctor

    If allergic reaction or irritation occurs.
    If you are pregnant, nursing or under medical treatment.

  • Storage

    Store in a dry and cool place away from direct sunlight.

  • Manufactured by

    Sichuan Fragrant Plant Biotechnology Co, Ltd

    Shigao Industrial Park, Tianfu New District, Xinjia Village, Shigao Town, Renshou County, Chengdu, Sichuan, China 610020

    Phone: 86-28-83503710

  • Inactive Ingredients

    FERRIC OXIDE RED, APPLE CIDER VINEGAR, SHRIMP SHELL CHITIN, SCHORL TOURMALINE, POLYETHYLENE GLYCOL 200, PANAX NOTOGINSENG ROOT, SALVIA MILTIORRHIZA ROOT, HIPPOPHAE RHAMNOIDES FRUIT, GYNOSTEMMA PENTAPHYLLUM LEAF

  • Drug Facts

    image description

  • INGREDIENTS AND APPEARANCE
    FOOT DETOX 
    zinc oxide patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70837-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION8.3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    APPLE CIDER VINEGAR (UNII: 0UE22Q87VC)  
    SHRIMP SHELL CHITIN (UNII: 8SH93A7QWW)  
    SCHORL TOURMALINE (UNII: 173O8XLY6T)  
    POLYETHYLENE GLYCOL 200 (UNII: R95B8J264J)  
    PANAX NOTOGINSENG ROOT (UNII: GQX1C1175U)  
    SALVIA MILTIORRHIZA ROOT (UNII: 1693AM5SBN)  
    HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T)  
    GYNOSTEMMA PENTAPHYLLUM LEAF (UNII: 5DWS84R85M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70837-001-0130 in 1 BOX05/09/2016
    1100 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34705/09/2016
    Labeler - Sichuan Fragrant Plant Biotechnology Co, Ltd (544412923)
    Registrant - Sichuan Fragrant Plant Biotechnology Co, Ltd (544412923)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sichuan Fragrant Plant Biotechnology Co, Ltd544412923manufacture(70837-001)
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