Label: FEMININE REPLENISH- spiranthes autumnalis suppository

  • 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 November 14, 2018

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  • ACTIVE INGREDIENT

    ​ACTIVE INGREDIENTS​

    Spiranthes Autumnalis 6C 1% HPUS*

  • INDICATIONS & USAGE

    ​USES​

    Designed to support tender vaginal tissue and aid in the dryness and discomfort common in peri-menopausal and menopausal women.

  • WARNINGS

    ​WARNING

    • Do not use if you are sensitive or allergic to any listed ingredients

    • If you are pregnant or breast feeding consult a health professional before use

    • Keep out of reach of children

    • Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    ​DIRECTIONS​

    • Insert one suppository vaginally at bedtime for maximum absorption

    • Wash hands before and afer use

    • Refrigerate to extend the shelf life of this extremely pure product

    • Use as needed

  • OTHER SAFETY INFORMATION

    ​TAMPER EVIDENCE

    • Do not use if the tamper proof seal is broken or missing.

  • INACTIVE INGREDIENT

    Agonis Fragrans Flower Oil°, Aniba Rosaeodora Wood Oil° (Rosewood). Anthemis Nobilis Flower Oil° (Roman Chamomile)°, Arrow Root°, Calendula Officinalis Oil°, Cera Alba° (Organic Beeswax) Cocos Nucifera Oil°, Matricaria Recutita° (German Chamomile), Pelaronium Graveolens Oil°, Retinyl Palmimate (Vitamin A) Ribes Nigrum Seed Oil, Rosa Damascena Oil°, Salvia Sclarea Oil°, Theobroma Cocao Seed Butter°" Thioctic Acid (Alpha Lipoic Acid), Tocopheryl Acetate (Vitamin E) °​Organic or Wilfcrafted Ingredients

  • QUESTIONS

    Manufactured for NOVABOTANICA INC. ι Made in USA - Bend OR 97708

    ® NOVABOTANICA is a registered trademark ι ​novabotanica.net

  • PRINCIPAL DISPLAY PANEL

    ​NOVA

    BOTANICA

    ​FEMININE 

    REPLENISH

    ​Homeopathic & Botanical Support

    ​To Nourish Delicate Feminine Tissue

    ​10 SUPPOSITORIES

    image description

    ​PURPOSE

    For Vaginal Dryness+

  • INGREDIENTS AND APPEARANCE
    FEMININE REPLENISH 
    spiranthes autumnalis suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69459-111
    Route of AdministrationVAGINAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SPIRANTHES SPIRALIS ROOT (UNII: 1E0M53AOMT) (SPIRANTHES SPIRALIS ROOT - UNII:1E0M53AOMT) SPIRANTHES SPIRALIS ROOT6 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    FAGONIA ARABICA WHOLE (UNII: E5BQJ3ZADS)  
    ROSEWOOD OIL (UNII: F2522O5L7B)  
    CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)  
    MARANTA ARUNDINACEA WHOLE (UNII: S4BQ65232F)  
    CALENDULA OFFICINALIS SEED OIL (UNII: 9JS8DS42SV)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ)  
    PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)  
    VITAMIN A (UNII: 81G40H8B0T)  
    RIBES NIGRUM SEED OIL (UNII: GKE1188837)  
    ROSA DAMASCENA FLOWER OIL (UNII: 18920M3T13)  
    SALVIA SCLAREA SEED OIL (UNII: JK0RP5O3HW)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    THIOCTIC ACID (UNII: 73Y7P0K73Y)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69459-111-1010 in 1 PACKAGE; Type 0: Not a Combination Product11/12/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/12/2018
    Labeler - Nova Botanica Inc. (013389488)
    Registrant - OHM PHARMA INC. (030572478)
    Establishment
    NameAddressID/FEIBusiness Operations
    OHM PHARMA INC.030572478manufacture(69459-111)
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