Label: OTOFLAM HP (belladonna, conium maculatum, dulcamara, ferrum phosphoricum, hepar sulphuris calcareum, kali bichromicum, mercurius solubilis, pulsatilla- pratensis, silicea, chamomilla. liquid

  • Category: HUMAN OTC DRUG LABEL

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 September 1, 2021

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  • ACTIVE INGREDIENTS:

    (in each drop): 10% of Belladonna 30X, Chamomilla 30C, Conium Maculatum 30X, Dulcamara 30X, Ferrum Phosphoricum 30X, Hepar Sulphuris Calcareum 30X, Kali Bichromicum 30X, Mercurius Solubilis 30X, Pulsatilla 30X, Silicea 30X.

  • INDICATIONS:

    May temporarily relieve ear pain and swelling.**

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

  • WARNINGS:

    If pregnant or breast-feeding, 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:

    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 4 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

  • INDICATIONS AND USAGE:

    May temporarily relieve ear pain and swelling.**

    **Claims based on traditional homeopathic practice, not accepted 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

    OTOFLAM HP

    1 fl. oz. (30 ml)

    Otoflam HP

  • INGREDIENTS AND APPEARANCE
    OTOFLAM  HP
    belladonna, conium maculatum, dulcamara, ferrum phosphoricum, hepar sulphuris calcareum, kali bichromicum, mercurius solubilis, pulsatilla (pratensis), silicea, chamomilla. liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44911-0513
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ATROPA BELLADONNA WHOLE (UNII: DSV74G1P2J) (ATROPA BELLADONNA WHOLE - UNII:DSV74G1P2J) ATROPA BELLADONNA WHOLE30 [hp_X]  in 1 mL
    CONIUM MACULATUM FLOWERING TOP (UNII: Q28R5GF371) (CONIUM MACULATUM FLOWERING TOP - UNII:Q28R5GF371) CONIUM MACULATUM FLOWERING TOP30 [hp_X]  in 1 mL
    SOLANUM DULCAMARA TOP (UNII: KPS1B1162N) (SOLANUM DULCAMARA TOP - UNII:KPS1B1162N) SOLANUM DULCAMARA TOP30 [hp_X]  in 1 mL
    FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERROSOFERRIC PHOSPHATE30 [hp_X]  in 1 mL
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE30 [hp_X]  in 1 mL
    POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V) POTASSIUM DICHROMATE30 [hp_X]  in 1 mL
    MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS30 [hp_X]  in 1 mL
    ANEMONE PRATENSIS (UNII: 8E272251DI) (ANEMONE PRATENSIS - UNII:8E272251DI) ANEMONE PRATENSIS30 [hp_X]  in 1 mL
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE30 [hp_X]  in 1 mL
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA30 [hp_C]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44911-0513-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product10/03/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/03/2019
    Labeler - Energique, Inc. (789886132)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(44911-0513) , api manufacture(44911-0513) , label(44911-0513) , pack(44911-0513)
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