Label: HERBAL POWER ALTERNATIVE HOMEOPATHIC AMAZING WOUND TREATMENT SKIN CREAM- calendula officinalis, echinacea angustifolia 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 March 12, 2021

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  • Active Ingredients

    Calendula officinalis 2X

    Echinacea angustifolia 2X

  • Purpose

    Calendula officinalis: wound healing, superficial burns, sunburn and scalds

    Echinacea angustifolia: dry and itchy skin, skin irritation from insect bites

  • Uses

    Helps relieve chafed, chapped, or cracked skin and also temporarily protects minor:

    • cuts
    • scrapes
    • burns
  • Warnings

    For external use only

    When using this product avoid contact with eyes, do not apply to deep or puncture wounds

    Stop use and ask a doctor if condition worsens or symptoms do not improve within 7 days

    Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

  • Directions

    • Gently cleanse and dry area.
    • Apply liberally to affected areas as needed.
  • Inactive Ingredients

    Arnica, Beeswax, Chamomile, Clove oil, Coconut oil, Dandelion, Lanolin, Lavender, Nettle leaf, Nutmeg, Olive oil, Sage, Shea butter, Tea tree oil, Yarrow

  • Principal Display Panel

    57 g NDC: 81386-001-57

    Homeopathic Cream 57 g

  • INGREDIENTS AND APPEARANCE
    HERBAL POWER ALTERNATIVE  HOMEOPATHIC AMAZING WOUND TREATMENT SKIN CREAM
    calendula officinalis, echinacea angustifolia cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81386-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA2 [hp_X]  in 57 g
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD) CALENDULA OFFICINALIS FLOWER2 [hp_X]  in 57 g
    Inactive Ingredients
    Ingredient NameStrength
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    CHAMOMILE (UNII: FGL3685T2X)  
    SAGE (UNII: 065C5D077J)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    NUTMEG (UNII: AEE24M3MQ9)  
    ACHILLEA MILLEFOLIUM OIL (UNII: 97P5D0WG43)  
    PEG-8 BEESWAX (UNII: 3C1QUF1TIR)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    TARAXACUM OFFICINALE (UNII: 39981FM375)  
    LANOLIN (UNII: 7EV65EAW6H)  
    CLOVE OIL (UNII: 578389D6D0)  
    URTICA DIOICA LEAF (UNII: X6M0DRN46Q)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81386-001-5757 g in 1 CONTAINER; Type 0: Not a Combination Product03/12/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/12/2021
    Labeler - BELLS & MORE INC (062687690)
    Establishment
    NameAddressID/FEIBusiness Operations
    BELLS & MORE INC062687690manufacture(81386-001)
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