Label: REMEDI HEALTH SOLUTIONS BURN RELIEF- calendula officinalis, capsicum annuum, cantharis vesicatoria, utrica urens 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 6, 2021

If you are a consumer or patient please visit this version.

  • DRUG FACTS

  • HPUS Active Ingredients

    CALENDULA OFFICINALIS 3x, 6c, 30c, 200c 
    CAPSICUM ANNUUM 30c 
    CANTHARIS VESICATORIA 30c
    UTRICA URENS 30c

  • Purpose

    CALENDULA OFFICINALIS 3x, 6c, 30c, 200c .........Speed heals, reduces scarring, burning pain, redness,
                                                                                       blistering, peeling, urticaria, blotches
    CAPSICUM ANNUUM 30c ....................................Burning pain, Redness
    CANTHARIS VESICATORIA 30c ............................Blistering, peeling
    UTRICA URENS 30c.............................................Urticaria, blotches

  • USES

    For pain relief, and accelerated healing of burns. Diminishes blistering. Great for Kids!

  • WARNINGS

    Do not use if seal is broken or missing.

    As with any drug, ask a doctor before use if pregnant or breastfeeding. This formula is highly diluted homeopathic and is generally safe for all ages. Call your provider if symptoms worsen after 7 days. Homeopathic Remedies have no known drug interactions.

    Keep this and all medication out of the reach of children. In case of accidental overdose contact a medical professional or Poison Control Center immediately. The active homeopathic ingredients are diluted beyond 1 part per million.

  • DIRECTIONS

    Apply to burned area. Spray topically or orally under tongue, every 5 minutes, 3 times in a row. Repeat every 20 minutes, 3 times in a row, then use as needed for up to 7 days. Pain relief and speed of healing should be obvious. Seek professional help if not resolving in a timely manner.

  • Inactive Ingredients:

    Aqua, Deionized Water, Glycerin, Potassium Sorbate, Sodium Benzoate

  • Questions/Comments? Side Effects?

    TOLL FREE: Call 855 - 777 - 5875

  • SPL UNCLASSIFIED SECTION

    Authentic Time-Tested Health Products

    Relief of pain & blistering

    Homeopathic remedies have been effective and safe for over 200 years.

    SUGAR FREE
    DAIRY FREE
    SOY FREE
    GLUTEN FREE
    NON-GMO

    Customers love this product!

    SATISFACTION GUARANTEED

    TAKE ME HOME!

    Urgent Care! Great for Kitchens and First Aid!

    ANTIBIOTIC FREE!

    No known drug interactions

    HIGH POTENCY
    FASTER ACTING

    100% Natural • 100% Drug Free
    Fast Acting • Zero Side Effects
    Safe for All Ages

    HOMEOPATHELLENSTURBO®
    PO Box 6
    Stevensville, MT 59870
    Since 1993
    Toll Free (855) 777-5875
    RemediHealthSolutions.com

    Manufactured by: PURE SOURCE LLC
    9750 NW17th St., Miami, FL 33172

    NDC# 5998530532

  • Packaging

    Burnrlf

  • INGREDIENTS AND APPEARANCE
    REMEDI HEALTH SOLUTIONS  BURN RELIEF
    calendula officinalis, capsicum annuum, cantharis vesicatoria, utrica urens spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59985-305
    Route of AdministrationORAL, TOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP30 [hp_C]  in 30 mL
    CAPSICUM ANNUUM WHOLE (UNII: 7FKZ3QQQ1F) (CAPSICUM ANNUUM WHOLE - UNII:7FKZ3QQQ1F) CAPSICUM ANNUUM WHOLE30 [hp_C]  in 30 mL
    LYTTA VESICATORIA (UNII: 3Q034RO3BT) (LYTTA VESICATORIA - UNII:3Q034RO3BT) LYTTA VESICATORIA30 [hp_C]  in 30 mL
    URTICA URENS WHOLE (UNII: IHN2NQ5OF9) (URTICA URENS - UNII:IHN2NQ5OF9) URTICA URENS WHOLE30 [hp_C]  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59985-305-321 in 1 BOX01/01/2019
    130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/01/2019
    Labeler - Chc Montana (101745243)