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KIDS RELIEF CALENDULA (HOMEOLAB USA INC)

Available Formats

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CREAM 1 TUBE in 1 CARTON (60512-9087-1) > 50 g in 1 TUBE Label Information

Complete KIDS RELIEF CALENDULA Information

  • 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 tube seal is broken.

    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.


  • CARTON

    image of carton label


  • TUBE

    image of tube label


  • INGREDIENTS AND APPEARANCE
    KIDS RELIEF CALENDULA 
    calendula officinalis, echinacea angustifolia, hypericum perforatum, phytolacca decandra, cantharis, sulphur cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:60512-9087
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP 1 [hp_X]  in 50 g
    ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA 1 [hp_X]  in 50 g
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM 3 [hp_X]  in 50 g
    PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT 3 [hp_X]  in 50 g
    LYTTA VESICATORIA (UNII: 3Q034RO3BT) (LYTTA VESICATORIA - UNII:3Q034RO3BT) LYTTA VESICATORIA 3 [hp_X]  in 50 g
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 3 [hp_X]  in 50 g
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:60512-9087-1 1 in 1 CARTON
    1 50 g in 1 TUBE
    2 NDC:60512-9087-2 6 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 03/15/2012
    Labeler - HOMEOLAB USA INC (202032533)
    Establishment
    Name Address ID/FEI Business Operations
    HOMEOLAB USA INC 202032533 manufacture(60512-9087)