Label: GROWTH SUPPORTPATCH, HAUTUKI (cholecalciferol- vitamin d3 patch

  • 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 May 22, 2023

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

View All Sections
  • ACTIVE INGREDIENT

    Capsicum annuum extract

  • INACTIVE INGREDIENT

    Hydrogenated Dicyclopentadiene/Isopentene/Isoprene/Styrene Copolymer (and) Mineral Oil (and) Hydrogenated Styrene/Butadiene Copolymer, coffee seed extract, soil mineral, cordycepin

  • PURPOSE

    It delivers nutrients such as vitamins in the patch to the body.

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    Use 1 patch per day (* 4hours per day). Children 4yrs & up. i.e back of hand, forearm, around knee,
    back of foot. Avoid using lotion or creams in area of application as it will hinder absorption. Patchs
    are water resistant NOT waterproof.

  • WARNINGS

    Do not use on damaged, broken or irritated skin. Keep out of reach of children 18 years or younger.

  • DOSAGE & ADMINISTRATION

    for external use only

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    GROWTH SUPPORTPATCH, HAUTUKI 
    cholecalciferol (vitamin d3) patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83463-0002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL0.2 mg  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM LACTATE (UNII: 2URQ2N32W3)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    PHYTONADIONE (UNII: A034SE7857)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83463-0002-130 in 1 PACKAGE05/01/2023
    10.25 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/01/2023
    Labeler - CUSTICS (695734126)
    Registrant - CUSTICS (695734126)
    Establishment
    NameAddressID/FEIBusiness Operations
    CUSTICS695734126manufacture(83463-0002)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!