Label: WELLHEAL- aesculus hipp, calendula off, equisetum arv, symphytum off, salix alba, stellaria med, mezereum off, uritca urens, althaea off, hamamelis vir cream

  • NDC Code(s): 72683-001-01
  • Packager: Proximity Capital Partners LLC dba Asutra
  • 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 7, 2020

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  • ACTIVE INGREDIENT

    All active ingredients are HPUS* in equal proportion at 2x potency

    Aesculus Hipp., Calendula Off., Equisetum Arv., Symphytum Off.

    Salix Alba, Stellaria Med.

    Mezereum Off., Urtica Urens

    Althaea Off., Hamamelis Vir.

    *HPUS indicates active ingredients are in the official Homeopathic Pharmacopeia of the United States.

  • PURPOSE

    All active ingredients are HPUS* in equal proportion at 2x potency

    Aesculus Hipp., Calendula Off., Equisetum Arv., Symphytum Off. ................................Promotes Wound Healing

    Salix Alba, Stellaria Med. ......................................Topical Analgesic

    Mezereum Off., Urtica Urens ................................ Reduces Itching

    Althaea Off., Hamamelis Vir. .................................Anti-inflammatory

    *HPUS indicates active ingredients are in the official Homeopathic Pharmacopeia of the United States.

  • INDICATIONS & USAGE

    • Helps reduce potential infection in minor cuts, scrapes, and abrasions.
    • For temporary relief of itchiness and soreness.
    • Promotes wound healing.

    Indications are based on Materia Medica, not clinical tests.

  • WARNINGS

    For external use only.

    Do not use if you have:

    • deep or puncture wounds
    • animal bites
    • serious burns
    • rash develops

    -----

    Do not use:

    • over large areas of the body
    • in eyes

    Stop use and ask doctor if:

    • condition worsens or lasts more than 1 week
    • symptoms clear up and reoccur within a few days

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

  • DOSAGE & ADMINISTRATION

    • clean the affected area
    • apply a small amount of this product on the area 2 to 3 times daily
    • may be covered with a steril bandage
  • STORAGE AND HANDLING

    • Store in a cool, dry place
    • Avoid direct sunlight
    • Tamper-evident for your protection. Use only if safety seal is intact.
  • INACTIVE INGREDIENT

    Colloidal Silver Citrate, Purified Water, Caprylyl Glycol, Aloe Vera Barbadensis (BiAloe), Methyl Glucose Dioleate, Carbomer, Sodium Hydroxide, Baobab Oil, Clove Oil, Potassium Sorbate, Citric Acid, Hyaluronic Acid

  • QUESTIONS

    1-888-819-6472

    Monday - Friday, 9am - 5pm CT

    Report any serious side effects to number above.

  • PRINCIPAL DISPLAY PANEL

    001

  • INGREDIENTS AND APPEARANCE
    WELLHEAL 
    aesculus hipp, calendula off, equisetum arv, symphytum off, salix alba, stellaria med, mezereum off, uritca urens, althaea off, hamamelis vir cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72683-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    EQUISETUM ARVENSE TOP (UNII: 1DP6Y6B65Z) (EQUISETUM ARVENSE TOP - UNII:1DP6Y6B65Z) EQUISETUM ARVENSE TOP3 [hp_X]  in 1 g
    SALIX ALBA BARK (UNII: 205MXS71H7) (SALIX ALBA BARK - UNII:205MXS71H7) SALIX ALBA BARK3 [hp_X]  in 1 g
    STELLARIA MEDIA (UNII: 2H03479QVR) (STELLARIA MEDIA - UNII:2H03479QVR) STELLARIA MEDIA3 [hp_X]  in 1 g
    URTICA URENS (UNII: IHN2NQ5OF9) (URTICA URENS - UNII:IHN2NQ5OF9) URTICA URENS3 [hp_X]  in 1 g
    HORSE CHESTNUT (UNII: 3C18L6RJAZ) (HORSE CHESTNUT - UNII:3C18L6RJAZ) HORSE CHESTNUT3 [hp_X]  in 1 g
    COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT3 [hp_X]  in 1 g
    DAPHNE MEZEREUM BARK (UNII: X2N6E405GV) (DAPHNE MEZEREUM BARK - UNII:X2N6E405GV) DAPHNE MEZEREUM BARK3 [hp_X]  in 1 g
    ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H) (ALTHAEA OFFICINALIS ROOT - UNII:TRW2FUF47H) ALTHAEA OFFICINALIS ROOT3 [hp_X]  in 1 g
    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 g
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP3 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ADANSONIA DIGITATA SEED OIL (UNII: 77MKL7AR5I)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    METHYL GLUCOSE DIOLEATE (UNII: FA9KFJ4Z6P)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CLOVE OIL (UNII: 578389D6D0)  
    SILVER CITRATE (UNII: CKA421A1J7)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72683-001-011 in 1 CARTON03/18/2019
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/18/2019
    Labeler - Proximity Capital Partners LLC dba Asutra (081214985)
    Establishment
    NameAddressID/FEIBusiness Operations
    BioLyte Laboratories, LLC015560564manufacture(72683-001)
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