Label: KIDS RELIEF CALENDULA- calendula officinalis, echinacea angustifolia, hypericum perforatum, phytolacca decandra, cantharis, sulphur cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated November 7, 2016

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  • ACTIVE INGREDIENTS HPUS

    Calendula officinalis (Marigold) 1X
    Echinacea angustifolia (Coneflower) 1X
    Hypericum perforatum (St John's wort) 3X
    Phytolacca decandra (American nightshade) 3X
    Cantharis (Spanish fly) 3X
    Sulphur (Sulfur) 3X

  • PURPOSE

    Cuts, burns
    Itching skin
    Scrapes, scars
    Itchy dry skin
    Burning pain
    Chapped rough skin

    These claims have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice.

  • REFERENCES

    The letters "HPUS" indicate that the components in this product are officially monographed in the Homoeopathic Pharmacopoeia of the United States.

  • USES

    This homeopathic medicine is made from a combination of ingredients traditionally used to help:

    - promote healing of minor cuts, scrapes, scars and burns

    - soften itchy dry, rough or chapped skin.

  • WARNINGS


    For external use only.

    Do not use if film wrapper is broken or missing.

    When using this product, avoid contact with eyes; if contact occurs, rinse abundantly with water to remove.

    Stop use and ask a doctor

    - if symptoms persist for more than 3 days or worsen

    - if hypersensitivity and/or allergy occurs.

    Keep out of reach of children. If ingested, get medical help or contact a Poison Control Center immediately.

  • DIRECTIONS

    - Clean affected area and apply a thin layer 3 times a day or as needed. May be covered with a sterile bandage.

    - Children under 2 yrs: ask a doctor.

  • OTHER INFORMATION

    Store at room temperature (68 - 77°F).

  • INACTIVE INGREDIENTS

    Carbomer, ceteareth-12, cetearyl alcohol, cetyl alcohol, cetyl palmitate, DMDM hydantoin, glycerin, glyceryl cocoate, glyceryl stearate, iodopropynyl butylcarbamate, isopropyl myristate, isopropyl palmitate, octyldodecanol, PEG-20 glyceryl stearate, PEG-100 stearate, purified water, sodium hydroxide, sorbitan stearate.

  • LABEL

    label

  • INGREDIENTS AND APPEARANCE
    KIDS RELIEF CALENDULA 
    calendula officinalis, echinacea angustifolia, hypericum perforatum, phytolacca decandra, cantharis, sulphur cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60512-9204
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP1 [hp_X]  in 50 g
    ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA1 [hp_X]  in 50 g
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM3 [hp_X]  in 50 g
    PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT3 [hp_X]  in 50 g
    LYTTA VESICATORIA (UNII: 3Q034RO3BT) (LYTTA VESICATORIA - UNII:3Q034RO3BT) LYTTA VESICATORIA3 [hp_X]  in 50 g
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR3 [hp_X]  in 50 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE A (UNII: F68VH75CJC)  
    CETEARETH-12 (UNII: 7V4MR24V5P)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL COCOATE (UNII: WVK1CT5994)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    PEG-20 GLYCERYL STEARATE (UNII: MJV0165YY8)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60512-9204-150 g in 1 JAR; Type 0: Not a Combination Product11/07/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/07/2016
    Labeler - HOMEOLAB USA INC (202032533)
    Establishment
    NameAddressID/FEIBusiness Operations
    HOMEOLAB USA INC202032533manufacture(60512-9204)
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