Label: RENELIX- benzoic acid, nitric acid, apis mellifera, berberis vulgaris root bark, colchicum autumnale bulb, protortonia cacti, solidago virgaurea flowering top, and capsella bursa-pastoris top solution/ drops

  • NDC Code(s): 59469-315-10, 59469-315-40
  • Packager: PEKANA Naturheilmittel GmbH
  • 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 11, 2023

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  • ACTIVE INGREDIENT

    Ingredients:
    Acidum benzoicum e resina4X
    Acidum nitricum6X
    Apis mellifica4X
    Berberis vulgaris3X
    Colchicum autumnale12X
    Dactylopius coccus (Coccus cacti)12.62 mg/ml
    Solidago virgaurea58.26 mg/ml
    Capsella bursa pastoris (Thlaspi bursa pastoris)10.20 mg/ml

    Selected ingredients prepared by spagyric processes.

  • INACTIVE INGREDIENT

    Contains 25% alcohol by volume.

  • Indications

    Helps cleanse and detoxify the body. Application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. With severe forms of this disease, a clinically proven therapy is indicated.

  • Dosage

    Unless otherwise prescribed, adults take 15-20 drops, 3 times per day. For pediatric dosages, consult your practitioner.

  • Warning

    If symptoms persist, contact a licensed practitioner. If you have known sensitivity to any of the ingredients, please consult your licensed practitioner before use. If you are pregnant or nursing a baby, seek the advice of a health care professional before use.

    Keep out of the reach of children.

  • STORAGE AND HANDLING

    Protect from light and heat.

  • Tamper Evident

    Do not use this product if tamper evident strip is broken or removed from base of cap.

  • QUESTIONS

    To report adverse events, contact BioResource at 321B Blodgett Street, Cotati, CA 94931

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    BioResource Inc.
    Cotati, CA 94931

    Manufactured by:
    PEKANA® GmbH
    D-88353 Kisslegg

  • PRINCIPAL DISPLAY PANEL - 100 ml Bottle Box

    RENELIX™

    Oral Drops

    Homeopathic Medicine

    Helps cleanse and
    detoxify the body

    3.34 FL OZ
    (100 ml)

    PEKANA®

    PRINCIPAL DISPLAY PANEL - 100 ml Bottle Box
  • INGREDIENTS AND APPEARANCE
    RENELIX 
    benzoic acid, nitric acid, apis mellifera, berberis vulgaris root bark, colchicum autumnale bulb, protortonia cacti, solidago virgaurea flowering top, and capsella bursa-pastoris top solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59469-315
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOIC ACID (UNII: 8SKN0B0MIM) (BENZOIC ACID - UNII:8SKN0B0MIM) BENZOIC ACID4 [hp_X]  in 50 mL
    NITRIC ACID (UNII: 411VRN1TV4) (NITRIC ACID - UNII:411VRN1TV4) NITRIC ACID6 [hp_X]  in 50 mL
    APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA4 [hp_X]  in 50 mL
    BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U) BERBERIS VULGARIS ROOT BARK3 [hp_X]  in 50 mL
    COLCHICUM AUTUMNALE BULB (UNII: 993QHL78E6) (COLCHICUM AUTUMNALE BULB - UNII:993QHL78E6) COLCHICUM AUTUMNALE BULB12 [hp_X]  in 50 mL
    PROTORTONIA CACTI (UNII: LZB7TFX1LT) (PROTORTONIA CACTI - UNII:LZB7TFX1LT) PROTORTONIA CACTI631 mg  in 50 mL
    SOLIDAGO VIRGAUREA FLOWERING TOP (UNII: 5405K23S50) (SOLIDAGO VIRGAUREA FLOWERING TOP - UNII:5405K23S50) SOLIDAGO VIRGAUREA FLOWERING TOP2913 mg  in 50 mL
    CAPSELLA BURSA-PASTORIS TOP (UNII: 7D8DU3293G) (CAPSELLA BURSA-PASTORIS TOP - UNII:7D8DU3293G) CAPSELLA BURSA-PASTORIS TOP510 mg  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59469-315-101 in 1 BOX06/24/2019
    150 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    2NDC:59469-315-401 in 1 BOX06/24/2019
    2100 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC06/24/2019
    Labeler - PEKANA Naturheilmittel GmbH (320344542)
    Establishment
    NameAddressID/FEIBusiness Operations
    PEKANA Naturheilmittel GmbH320344542MANUFACTURE(59469-315)
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