Label: NEORELIEF FOR MENSTRUAL PAIN AND CRAMPS- homeopathic pain relief gel gel

  • NDC Code(s): 58368-003-03
  • Packager: BioLyte Laboratories, 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 January 11, 2024

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  • Drug Facts Active Ingredients

    All actives are HPUS* and 4X potency.

    Apis, Arnica, Belladonna, Bryonia, Cimicifuga, Cyclamen, Joneosia, Kali Carb., Lilium, Rhamnus Calif., Sabina

    Bellis, Cactus, Caulophyllum, Colocynthis, Gelsemium, Viburnum

    Tilia

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

  • Purpose

    Topical Analgesics

    Relief of Cramping

    Anti-inflammatory

  • Uses

    For temporary relief of menstrual symptoms such as:

    Menstrual pain, Cramping

    Indications are based on homeopathic materia medica, not clinical tests.

  • Warnings

    For external use only

    Do not use on damged or broken skin.

    Keep out of eyes, open wounds, mucous membranes

  • Warnings

    Stop use and ask doctor if:

    Condition worsens or persists,

    rash develops

  • Warnings

    If pregnant or breastfeeding consult your doctor before use.

  • Warnings

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

  • Directions

    Women ages 8 years and older, spread thin layer on lower abdomen and lower back.

    Do not apply over other topical lotions; they may hinder effectiveness.

    Apply as needed for relief.

  • Other Information

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

  • Inactive Ingredients

    Citric Acid, Fulvic Acid, Glycerin, Potassium Sorbate, Purified Water, Sodium Hydroxide, Ultrez-10 Polymer.

  • Questions or Comments?

    800.538.1455

    Monday through Friday, 8 a.m. - 5 p.m. EST or visit us at neorelief.com.

    Reporty any serious side effects to the number above.

  • Addtional Label Content

    Packaging Recyclable

    Made in the USA

    Listed with the FDA

    neorelief.com

    Drug Facts continued peel here

    FTC required disclosure: Product efficacy and claims are based on theories of homeopathy that re not supported by scientific evidence and most modern allopathic medical professionals.

    BioLyte Labs Grand Rapids, MI 49534

  • NEORELIEF for Menstrual Pain and Cramps

    NDC 58368-003-03 Patent Pending

    Neo Relief

    Temporary relief of

    Menstrual pain & cramps

    Homeopathic pain relief gel

    Net Wt. 0.5 oz (14.17g)

    NeoRelief_Menstural

  • INGREDIENTS AND APPEARANCE
    NEORELIEF FOR MENSTRUAL PAIN AND CRAMPS 
    homeopathic pain relief gel gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58368-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D) POTASSIUM CARBONATE4 [hp_X]  in 1 g
    FRANGULA CALIFORNICA BARK (UNII: 1LZ13MQR0S) (FRANGULA CALIFORNICA BARK - UNII:1LZ13MQR0S) FRANGULA CALIFORNICA BARK4 [hp_X]  in 1 g
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA4 [hp_X]  in 1 g
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA4 [hp_X]  in 1 g
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT4 [hp_X]  in 1 g
    BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH4 [hp_X]  in 1 g
    CYCLAMEN PURPURASCENS TUBER (UNII: G728143D8Q) (CYCLAMEN PURPURASCENS TUBER - UNII:G728143D8Q) CYCLAMEN PURPURASCENS TUBER4 [hp_X]  in 1 g
    SARACA INDICA BARK (UNII: 341ALE870W) (SARACA INDICA BARK - UNII:341ALE870W) SARACA INDICA BARK4 [hp_X]  in 1 g
    LILIUM LANCIFOLIUM WHOLE FLOWERING (UNII: X67Z2963PI) (LILIUM LANCIFOLIUM WHOLE FLOWERING - UNII:X67Z2963PI) LILIUM LANCIFOLIUM WHOLE FLOWERING4 [hp_X]  in 1 g
    JUNIPERUS SABINA LEAFY TWIG (UNII: Z5BEX9K2G1) (JUNIPERUS SABINA LEAFY TWIG - UNII:Z5BEX9K2G1) JUNIPERUS SABINA LEAFY TWIG4 [hp_X]  in 1 g
    BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS4 [hp_X]  in 1 g
    SELENICEREUS GRANDIFLORUS STEM (UNII: 7114SV0MYK) (SELENICEREUS GRANDIFLORUS STEM - UNII:7114SV0MYK) SELENICEREUS GRANDIFLORUS STEM4 [hp_X]  in 1 g
    CAULOPHYLLUM THALICTROIDES ROOT (UNII: JTJ6HH6YEH) (CAULOPHYLLUM THALICTROIDES ROOT - UNII:JTJ6HH6YEH) CAULOPHYLLUM THALICTROIDES ROOT4 [hp_X]  in 1 g
    CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17) CITRULLUS COLOCYNTHIS FRUIT PULP4 [hp_X]  in 1 g
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT4 [hp_X]  in 1 g
    VIBURNUM OPULUS BARK (UNII: T1UG6H6805) (VIBURNUM OPULUS BARK - UNII:T1UG6H6805) VIBURNUM OPULUS BARK4 [hp_X]  in 1 g
    TILIA X EUROPAEA FLOWER (UNII: NHV2K1OUDH) (TILIA X EUROPAEA FLOWER - UNII:NHV2K1OUDH) TILIA X EUROPAEA FLOWER4 [hp_X]  in 1 g
    APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA4 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    FULVIC ACID (UNII: XII14C5FXV)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58368-003-031 in 1 CARTON04/27/2018
    114.17 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/27/2018
    Labeler - BioLyte Laboratories, LLC (015560564)
    Establishment
    NameAddressID/FEIBusiness Operations
    BioLyte Laboratories, LLC015560564manufacture(58368-003)
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