Label: CALENDULA PLUS- calendula officinalis, echinacea, hypericum perforatum, phytolacca decandra, cantharis, sulphur cream

  • Category: HUMAN OTC DRUG LABEL

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 December 14, 2018

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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

    Wounds, burns.

    Itching skin.

    Painful scars.

    Itchy dry skin.

    Burning pain.

    Chapped rough skin.

  • REFERENCES

    The letters HPUS indicate that these ingredients are officially included in the Homeopathic Pharmacopoeia of the United States.

  • USES

    This homeopathic medicine helps:

    - promote healing of minor cuts, scrapes or burns

    - soften 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.

    Stop use and ask a doctor if symptoms persist for more than 3 days or worsen.

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS

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

  • OTHER INFORMATION

    Store at room temperature (68-77F).

  • 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
    CALENDULA PLUS 
    calendula officinalis, echinacea, hypericum perforatum, phytolacca decandra, cantharis, sulphur cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60512-0050
    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
    WATER (UNII: 059QF0KO0R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PEG-20 GLYCERYL STEARATE (UNII: MJV0165YY8)  
    CETEARETH-12 (UNII: 7V4MR24V5P)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    GLYCERYL COCOATE (UNII: WVK1CT5994)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYOXYL 100 STEARATE (UNII: YD01N1999R)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    CARBOMER HOMOPOLYMER TYPE A (UNII: F68VH75CJC)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60512-0050-11 in 1 CARTON03/26/1997
    150 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/26/1997
    Labeler - HOMEOLAB USA INC (202032533)
    Establishment
    NameAddressID/FEIBusiness Operations
    HOMEOLAB USA INC202032533manufacture(60512-0050)
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