Label: COLD SORE RESCUE- borax, dulcamara, natrum muriaticum, ranunculus bulbosus, silicea gel

  • 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 August 2, 2022

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  • ACTIVE INGREDIENTS:


    (in gel): 0.20% of BORAX 30X, DULCAMARA 30X, NATRUM MURIATICUM 30X, RANUNCULUS BULBOSUS 30X, SILICEA 30X.

  • USES:

    May temporary relief symptoms of cold sores and fever blisters such as: stinging - itching - swelling of minor herpatic skin eruptions of the face or genitals.**

    **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

  • WARNINGS:

    For external use only.

    When using this product - Do not get into eyes.

    Stop use and ask a doctor if: Condition worsens - Symptoms last more than 7 days

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

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

    Do not use if tamper evident seal is broken or missing.

  • KEEP OUT OF REACH OF CHILDREN:

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

  • DIRECTIONS:

    Apply at least 3 times daily over affected area. Children under 12 years of age: Consult a doctor.

  • USES:

    May temporary relief symptoms of cold sores and fever blisters such as: stinging - itching - swelling of minor herpatic skin eruptions of the face or genitals.**

    **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

  • INACTIVE INGREDIENTS:

    Water, Chaparral (Larrea Tridentata) Leaf, Comfrey (Symphytum Officinale) Leaf, St. John’s Wort (Hypericum Perforatum) Aerial Parts, Poke (Phytolacca Americana) Root, Arnica (Arnica Montana) Flower, Lemon Balm (Melissa Officinalis) Leaf, White Willow (Salix Alba) Bark, Yarrow (Achillea Millefolium) Flower, English Lavender (Lavandula Angustifolia) Buds, Ascorbic Acid, Poke (Phytolacca Americana) Berries, Aloe Vera 10X Concentrate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, PEG-33, PEG-8 Dimethicone, PEG-14, Sodium Hydroxide, Tocopherols (Soy), Edetate Disodium (EDTA), Natural Plant Extract (Origanox WS), Potassium Sorbate, Sodium Benzoate, Alcohol, Citric Acid.

  • QUESTIONS:

    888-303-3388 Mon-Fri 8 a.m.-5 p.m. CT

    Dist. by Peaceful Mountain, Inc., Woodbine, IA 51579

    www.peacefulmountain.com

  • PACKAGE LABEL DISPLAY:

    homeopathic relief

    May temporarily relieve cold sore and fever blisters symptoms

    May help temporarily relieve stinging, burning, itching and swelling

    peaceful mountain

    THE HEIGHT OF HEALTH

    formulated in boulder, co

    cold sore rescue

    homeopathic gel

    Net wt. 0.25 oz. (7 g)

    Cold Sore Rescue Tube

    Cold Sore Rescue Carton

  • INGREDIENTS AND APPEARANCE
    COLD SORE RESCUE 
    borax, dulcamara, natrum muriaticum, ranunculus bulbosus, silicea gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43846-0031
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM BORATE (UNII: 91MBZ8H3QO) (BORATE ION - UNII:44OAE30D22) SODIUM BORATE30 [hp_X]  in 1 g
    SOLANUM DULCAMARA TOP (UNII: KPS1B1162N) (SOLANUM DULCAMARA TOP - UNII:KPS1B1162N) SOLANUM DULCAMARA TOP30 [hp_X]  in 1 g
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE30 [hp_X]  in 1 g
    RANUNCULUS BULBOSUS WHOLE (UNII: AEQ8NXJ0MB) (RANUNCULUS BULBOSUS WHOLE - UNII:AEQ8NXJ0MB) RANUNCULUS BULBOSUS WHOLE30 [hp_X]  in 1 g
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE30 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    LARREA TRIDENTATA LEAF (UNII: PK0TXD049P)  
    COMFREY LEAF (UNII: DG4F8T839X)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)  
    OREGANO (UNII: 0E5AT8T16U)  
    POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)  
    PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
    POLYETHYLENE GLYCOL 700 (UNII: 762678AC5R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SORBIC ACID (UNII: X045WJ989B)  
    PHYTOLACCA AMERICANA FRUIT (UNII: WE63661499)  
    PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ST. JOHN'S WORT (UNII: UFH8805FKA)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    SALIX ALBA BARK (UNII: 205MXS71H7)  
    ACHILLEA MILLEFOLIUM FLOWER (UNII: YQR8R0SQEA)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ALCOHOL (UNII: 3K9958V90M)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43846-0031-21 in 1 CARTON12/08/2014
    1NDC:43846-0031-17 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/08/2014
    Labeler - Peaceful Mountain, Inc. (078430707)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43846-0031) , api manufacture(43846-0031) , label(43846-0031) , pack(43846-0031)
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