Label: CUT AND WOUND REMEDY- topical cut and wound relief 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 December 6, 2017

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  • Olive Leaf Cut & Wound Remedy

    Arnica montana 6X

    Calendula officinalis 1X

    Hamamelis virginica 3X

    Hypericum perforatum 3X

    Ledum palustre 3X

  • Olive Leaf Cut & Wound Remedy

    Grapefruit Seed Extract, Olive Leaf Extract (Olea europaea), Sodium Chloride, USP Purified Water, Xylitol powder.

  • Olive Leaf Cut & Wound Remedy

    -Do not exceed recommended dosage.

    -This product is designed to provide relief and promote healing for superficial cuts and wounds on the surface of the skin. Should the wound be more than superficial seek immediate medical attention.

    -For your safety there is a full body seal over bottle printed "sealed for you protection". Do not use if seal is broken or missing.

  • Olive Leaf Cut & Wound Remedy

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Olive Leaf Cut & Wound Remedy

    A homeopathic remedy for the temporary relief and promotion of rapid healing of the skin for superficial injuries, cuts, punctures, abrasions, lacerations, bites, bruises, sores, stings, and painful wounds.

  • Olive Leaf Cut & Wound Remedy

    -First wash hands and the affected areas of the skin with warm soapy water, rinse and dry.

    -Remove protective cap.

    -Depress spray pump 2-3 times. Spray on cut or wound covering the entire area.

    -When finished wipe nozzle clean and replace cap.

    Adults and children 13 years and older - 2-3 sprays, every 2-4 hours or as needed.

    Children 3-12 years - Half the adult dose

    Children under 3 - Consult healthcare professional

  • Olive Leaf Cut & Wound Remedy

    Arnica montana - Relief for skin injury, bruises, tissue.

    Caledula officinalis - Promotes rapid healing of open wounds, superficial burns, sores, abrasions, lacerations, ulcers and suppurating wounds

    Hamamelis viginica - Relief for painful wounds, skin injuries, burns, inflammation, and lacerated wounds.

    Hypericum perforatum - Relief for punctures and lacerated wounds; tingling, burning, numbness and painful wounds; and bites and bruises of the skin.

    Ledum palustre - Promotes healing for puncture wounds; bites, stings, skin eruptions; and discoloration after injuries. Relieves pain after operations.

  • Olive Leaf Cut & Wound Remedy

    Label

    Carton

  • INGREDIENTS AND APPEARANCE
    CUT AND WOUND REMEDY 
    topical cut and wound relief spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64616-070
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA6 [hp_X]  in 1 mL
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP1 [hp_X]  in 1 mL
    HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK3 [hp_X]  in 1 mL
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM3 [hp_X]  in 1 mL
    LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) LEDUM PALUSTRE TWIG3 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRUS PARADISI SEED (UNII: 12F08874Y7)  
    OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64616-070-021 in 1 CARTON07/18/2011
    1NDC:64616-070-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/18/2011
    Labeler - Vitality Works, Inc. (137752817)
    Registrant - Vitality Works, Inc. (137752817)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vitality Works, Inc.137752817manufacture(64616-070)