Label: H-COLD SORES FORMULA- calendula officinalis, ranunculus bulbosus oil

  • NDC Code(s): 61077-127-11, 61077-127-33
  • Packager: Healing Natural Oils LLC
  • 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 26, 2019

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  • Active Ingredients:

    Calendula officinalis -12C HPUS,

    Ranunculus bulbosus- 12C HPUS   

  • Purpose

    Calendula officinalis -12C HPUS  (for herpes, healing agent),

    Ranunculus bulbosus -12C HPUS (herpetic eruptions)

    The letters ‘HPUS’ indicate that the components in this product are officially
    monographed in the Homoeopathic Pharmacopoeia of the United States

  • Inactive Ingredients:

    Essential Oil Blend (Cymbopogon martinii aerial parts,
    Lavandula officinalis flower bud, Litsea cubeba seed,
    Melaleuca alternifolia leaf-branch, Pelargonium graveolens whole
    plant)

  • Indications:

    For the treatment of cold sore symptoms, such as fever blisters, soreness at blister site.

  • Directions:

    Adults and Children 4 yrs and over: Wash hands before and after use.
    Shake well and apply 1 or 2 drops to a cotton swab and apply directly to the affected area 3x per day.
    Do not oversaturate or exceed dosage.

  • Warnings:

    For external use only.

    Perform skin test prior to initial use.





    Do not use if pregnant or breastfeeding.

    Keep out of reach of children.

    Keep away from eyes and mucous membranes. If swallowed get medical help

    or contact a Poison Control Center right away.

    Discontinue use if irritation occurs.

    Consult a doctor if symptoms worsen after 7 days.

  • DESCRIPTION

    Dist. by Healing Natural Oils 1042 N El Camino Real,

    #B-426, Encinitas, CA 92024 USA

  • Principal Display Panel

    Healing Natural Oils

    H-Cold Sores
    Formula

    Homeopathic

    For External Use Only

    127

    11ml (0.37 fl. oz)
    amoils.com

    H-Cold Sores Formula label


  • INGREDIENTS AND APPEARANCE
    H-COLD SORES FORMULA 
    calendula officinalis, ranunculus bulbosus oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61077-127
    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 TOP12 [hp_C]  in 11 mL
    RANUNCULUS BULBOSUS (UNII: AEQ8NXJ0MB) (RANUNCULUS BULBOSUS - UNII:AEQ8NXJ0MB) RANUNCULUS BULBOSUS12 [hp_C]  in 11 mL
    Inactive Ingredients
    Ingredient NameStrength
    CYMBOPOGON MARTINI TOP (UNII: 7K1N3UZ6DU)  
    LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    LITSEA CUBEBA FRUIT (UNII: R3617MQA5Z)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    PELARGONIUM GRAVEOLENS WHOLE (UNII: 0E553RP62F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61077-127-1111 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product11/06/2013
    2NDC:61077-127-3333 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product11/06/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/06/2013
    Labeler - Healing Natural Oils LLC (113679703)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio, Inc.617901350manufacture(61077-127)
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