KIDS RELIEF CALENDULA (CALENDULA OFFICINALIS, ECHINACEA ANGUSTIFOLIA, HYPERICUM PERFORATUM, PHYTOLACCA DECANDRA, CANTHARIS, SULPHUR) CREAM [HOMEOLAB USA INC]

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  • KIDS RELIEF CALENDULA (CALENDULA OFFICINALIS, ECHINACEA ANGUSTIFOLIA, HYPERICUM PERFORATUM, PHYTOLACCA DECANDRA, CANTHARIS, SULPHUR) CREAM [HOMEOLAB USA INC]

KIDS RELIEF CALENDULA (CALENDULA OFFICINALIS, ECHINACEA ANGUSTIFOLIA, HYPERICUM PERFORATUM, PHYTOLACCA DECANDRA, CANTHARIS, SULPHUR) CREAM [HOMEOLAB USA INC]
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NDC 60512-9087-1, 60512-9087-2
Set ID 46828c9d-0852-48d8-917b-ef85e0563094
Category HUMAN OTC DRUG LABEL
Packager HOMEOLAB USA INC
Generic Name
Product Class
Product Number
Application Number
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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 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:60512-9087
    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:60512-9087-11 in 1 CARTON
    150 g in 1 TUBE
    2NDC:60512-9087-26 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/15/2012
    Labeler - HOMEOLAB USA INC (202032533)
    Establishment
    NameAddressID/FEIBusiness Operations
    HOMEOLAB USA INC202032533manufacture(60512-9087)
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