Label: COSMESTAT (alfalfa, avena sativa, iodium, bovista, formalinum, hypophysis suis, manganum aceticum, natrum muriaticum, petroleum, pulsatilla (pratensis), rhus tox, terebinthina, thyroidinum- bovine, cortisone aceticum liquid

  • 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 April 17, 2023

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  • ACTIVE INGREDIENTS:

    (in each drop): 9.06% of Bovista 12X, Cortisone Aceticum 30X, Formalinum 12X, Hypophysis Suis 12X, Manganum Aceticum 12X, Natrum Muriaticum 12X, Petroleum 12X, Pulsatilla 12X, Rhus Tox 12X, Terebinthina 12X, Thyroidinum 12X; 0.10% of Alfalfa 3X, Avena Sativa 3X, Iodium 6X.

  • PURPOSE:

    For temporary relief of sinus congestion, dry cough in the evening and rhinitis.**

    **Claims based on traditional homeopathic practice, not medical evidence. Not FDA evaluated.

  • WARNINGS:

    If pregnant or breastfeeding, ask a health professional before use.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

    Do not use if tamper evident seal is broken or missing.

    Store in a cool, dry place.

  • KEEP OUT OF REACH OF CHILDREN:

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS:

    Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist for more than 7 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

  • INDICATIONS:

    For temporary relief of sinus congestion, dry cough in the evening and rhinitis.**

    **Claims based on traditional homeopathic practice, not medical evidence. Not FDA evaluated.

  • INACTIVE INGREDIENTS:

    Demineralized water, 20% Ethanol.

  • QUESTIONS:

    Dist. by Energique, Inc.
    201 Apple Blvd.
    Woodbine, IA 51579 800.869.8078

  • PACKAGE LABEL DISPLAY:

    ENERGIQUE

    SINCE 1987

    HOMEOPATHIC REMEDY

    COSMESTAT

    1 fl. oz. (30 ml)

    COSMESTAT

  • INGREDIENTS AND APPEARANCE
    COSMESTAT 
    alfalfa, avena sativa, iodium, bovista, formalinum, hypophysis suis, manganum aceticum, natrum muriaticum, petroleum, pulsatilla (pratensis), rhus tox, terebinthina, thyroidinum (bovine), cortisone aceticum liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44911-0671
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MEDICAGO SATIVA WHOLE (UNII: DJO934BRBD) (ALFALFA - UNII:DJO934BRBD) MEDICAGO SATIVA WHOLE3 [hp_X]  in 1 mL
    AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP3 [hp_X]  in 1 mL
    IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE6 [hp_X]  in 1 mL
    LYCOPERDON UTRIFORME FRUITING BODY (UNII: K2A74U428F) (LYCOPERDON UTRIFORME FRUITING BODY - UNII:K2A74U428F) LYCOPERDON UTRIFORME FRUITING BODY12 [hp_X]  in 1 mL
    FORMALDEHYDE SOLUTION (UNII: T0H3L6C7I5) (FORMALDEHYDE SOLUTION - UNII:T0H3L6C7I5) FORMALDEHYDE SOLUTION12 [hp_X]  in 1 mL
    SUS SCROFA PITUITARY GLAND (UNII: L0PFEMQ1DT) (SUS SCROFA PITUITARY GLAND - UNII:L0PFEMQ1DT) SUS SCROFA PITUITARY GLAND12 [hp_X]  in 1 mL
    MANGANESE ACETATE TETRAHYDRATE (UNII: 9TO51D176N) (MANGANOUS CATION - UNII:H6EP7W5457) MANGANESE ACETATE TETRAHYDRATE12 [hp_X]  in 1 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE12 [hp_X]  in 1 mL
    KEROSENE (UNII: 1C89KKC04E) (KEROSENE - UNII:1C89KKC04E) KEROSENE12 [hp_X]  in 1 mL
    PULSATILLA PRATENSIS WHOLE (UNII: 8E272251DI) (PULSATILLA PRATENSIS WHOLE - UNII:8E272251DI) PULSATILLA PRATENSIS WHOLE12 [hp_X]  in 1 mL
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF12 [hp_X]  in 1 mL
    TURPENTINE OIL (UNII: C5H0QJ6V7F) (TURPENTINE OIL - UNII:C5H0QJ6V7F) TURPENTINE OIL12 [hp_X]  in 1 mL
    THYROID, BOVINE (UNII: MN18OTN73W) (THYROID, BOVINE - UNII:MN18OTN73W) THYROID, BOVINE12 [hp_X]  in 1 mL
    CORTISONE ACETATE (UNII: 883WKN7W8X) (CORTISONE - UNII:V27W9254FZ) CORTISONE ACETATE30 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44911-0671-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product04/17/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/17/2023
    Labeler - Energique, Inc. (789886132)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(44911-0671) , api manufacture(44911-0671) , label(44911-0671) , pack(44911-0671)
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