Label: ALL NATURAL WOUND AND BURN- calendula officinalis flower, sambucus nigra flower, echinacea angustifolia spray

  • 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 January 11, 2024

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS

    CALENDULA OFFICINALIS (1X) HPUS (MARIGOLD)

    ECHINACEA ANGUSTIFOLIA (1X) HPUS (ECHINACEA)

    SAMBUCUS NIGRA (1X) HPUS (ELDERBERRY)

  • PURPOSE

    PURPOSE

    SWELLING, ITCHY SKIN, RED SPOTS WITH BURNING SENSATION

    WOUND HEALING, SUPERFICIAL BURNS, SUNBURN AND SCALDS

    DRY AND ITCHY SKIN, SKIN IRRITATION FROM INSECT BITES

  • INDICATIONS & USAGE

    USES: TEMPORARITY RELIEVES SYMPTOMS ASSOCIATED WITH MINOR SKIN WOUNDS,

    SUNBURN, SUPERFICIAL BURNS, SWELLING AND ITCHING. ALSO MAY BE USED TO CLEAN

    WOUNDS. PRODUCT USES ARE BASED ON HOMEOPATHIC MATERIA MEDICA. THESE "USES"

    HAVE NOT BEEN EVALUATED BY THE FDA.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS: TEST FOR ALLERGY BY APPLYING A SMALL AMOUNT ON SKIN BEFORE USE.

    APPLY TOPICALLY TO AFFECTED AREA 2-6 TIMES A DAY, OR AS DIRECTED BY YOUR PHYSICIAN.

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS: ORGANIC ALOE, ORGANIC OLIVE OIL (EXTRA VIRGIN), WILD HARVESTED PINE EXTRACT

  • WARNINGS

    WARNING: FOR EXTERNAL USE ONLY. DO NOT USE IF YOU HAVE AN ALLERGY OR

    HYPERSENSITIVITY TO THE COMPONENTS OF THE FORMULA OR IF YOU HAVE HAD

    PRIOR REACTION TO THIS SALVE, STOP USE AND ASK A DOCTOR IF SYMPTOMS

    PERSIST OR WORSEN. AVOID CONTACT WITH EYES.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • QUESTIONS

    QUESTIONS OR COMMENTS: CALL 818-851-9014 BETWEEN8:AM - 5:PM PST

  • PRINCIPAL DISPLAY PANEL

    Wound Burn Spray Label - 4 oz

  • INGREDIENTS AND APPEARANCE
    ALL NATURAL WOUND AND BURN 
    calendula officinalis flower, sambucus nigra flower, echinacea angustifolia spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52810-219
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD) CALENDULA OFFICINALIS FLOWER1 [hp_X]  in 100 mL
    ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA1 [hp_X]  in 100 mL
    SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T) (SAMBUCUS NIGRA FLOWER - UNII:07V4DX094T) SAMBUCUS NIGRA FLOWER1 [hp_X]  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE (UNII: V5VD430YW9)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    MARITIME PINE (UNII: 50JZ5Z98QY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52810-219-24118 mL in 1 BOTTLE; Type 0: Not a Combination Product09/09/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/09/2016
    Labeler - PUREMEDY (003552251)
    Establishment
    NameAddressID/FEIBusiness Operations
    PUREMEDY003552251manufacture(52810-219)
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