Label: DOLODENT MAX STRENGTH- arnica montana, asafoedida, chamomilla, hecla lava, hypericum 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 November 7, 2023

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  • Drug Facts

  • Active ingredients & Purposes

    Active ingredients**(HPUS) Purposes*
    Arnica montana 30XPain in the tooth, with inflammation
    Asa foetida 6XCavity pain
    Chamomilla vulgaris 30Irritation, toothache, sore gums
    Hekla lava 30XTooth sensitive to pressure, with swollen gums
    Hypericum perforatum 30XSharp shooting pain, due to toothache

    The letters HPUS indicate that this ingredient is officially included in the Homeopathic Pharmacopeia of the United States.

  • Uses*

    For the temporary relief of oral pain due to minor irritation of the mouth and gums.

  • Warnings

    Do not use

    • this product for more than 7 days
    • if you are allergic to any ingredients in this product

    Stop use and ask your doctor or dentist if

    • sore mouth symptoms do not improve in 7 days
    • irritation, pain, or redness persists or worsens
    • swelling, rash, or fever develops

    If pregnant or breastfeeding,

    seek professional advice before taking this product.

    Keep out of the reach of children.

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

  • Directions

    • shake well before use

    adults and children 12 years of age and over:

    • add 2-3 drops to a small piece of cotton or gauze
    • apply to the affected area and allow in place for at least 1 minute and spit out
    • repeat as needed

    children under 12 years of age: consult a dentist or doctor

  • Inactive ingredients

    clove oil, polysorbate 20, sucrose, water

  • Question & comments?

    +1-866-359-3478 (M-F) 9AM to 5PM EST or www.pharmadel.com

  • Distributed by:/ Distribuido por:

    PHARMADEL
    New Castle, DE 19720
    + 1-866-359-3478
    www.pharmadel.com

    Made in India

  • Homeopathic Statements

    *These “ USES” claims have not been evaluated by the Food and Drug Administration (FDA). They are based on traditional homeopathic practices.

    **C, K, CK and X are homeopathic dilutions.

  • Principal Display Panel

    DD PDP HW

  • INGREDIENTS AND APPEARANCE
    DOLODENT  MAX STRENGTH
    arnica montana, asafoedida, chamomilla, hecla lava, hypericum liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-400
    Route of AdministrationBUCCAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA30 [hp_X]  in 1 mL
    CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE30 [hp_X]  in 1 mL
    FERULA ASSA-FOETIDA RESIN (UNII: W9FZA51AS1) (FERULA ASSA-FOETIDA RESIN - UNII:W9FZA51AS1) FERULA ASSA-FOETIDA RESIN6 [hp_X]  in 1 mL
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM30 [hp_X]  in 1 mL
    HEKLA LAVA (UNII: C21158IIRK) (HEKLA LAVA - UNII:C21158IIRK) HEKLA LAVA30 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    WATER (UNII: 059QF0KO0R)  
    CLOVE OIL (UNII: 578389D6D0)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SUCROSE (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55758-400-151 in 1 BOX12/01/2023
    115 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/01/2023
    Labeler - Pharmadel LLC (030129680)
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