Label: TINNI-CALM- carboneum, sulphuratum, chamomilla, chininum, sulphuricum, salicylicum acidum, silicea oil

  • 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 December 10, 2020

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  • HPUS Active Ingredients

    HPUS Active Ingredients: Each does contains equal volumes of: Carboneum sulphuratum, Chamomilla, Chininum sulphuricum, Salicylicum acidicum, Silicea.

  • Uses†

    Uses†: For symptomatic treatment of ringing, buzzing, undesirable noises, and general discomfort in the ears.

    † as per various homeopathic materia medicas. These uses have not been evaluated by the FD, and product has not been clinically tested.

  • Warngings

    Warnings: For external use only. If symptoms persist or worsen, discontinue use immediately and consutle a healthcare professional. If pregnant or breastfeeding, as ka health professional before use. Keep this and all medication out of reach of children. Avoid using near eyes or mouth. If swallowed, get medical help or contact a Poison Control Center immediately.

    Discontinue sue if irritation or reaction occurs.

  • Directions

    Directions: Shake well before using. Use at firest sign of symptoms. Dispense a small amount into hands. Massage gently onto cartilage of ourter ear canal and outer nostrils. Inhale deeply and slowly maintaining stillness. Repeat as needed.

    FOR EXTERNAL USE ONLY

  • OTHER SAFETY INFORMATION

    Keep carton for additional drug facts and information.

    Tamper resistant for your protection.

    Use only if safety seal is intact.

  • Inactive Ingredients

    Inactive Ingredients: Grapeseed oil, ginger essential oil, cypress essential oil, grapefruit essential oil, lemon essential oil.

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all medication out of reach of children.

  • PREGNANCY OR BREAST FEEDING

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

  • PURPOSE

    Temporarily soothes symptoms associated with ringing in the ears.

  • PRINCIPAL DISPLAY PANEL

    Tinni-Calm Label

  • PRINCIPAL DISPLAY PANEL

    Tinni-Calm Carton

  • INGREDIENTS AND APPEARANCE
    TINNI-CALM 
    carboneum, sulphuratum, chamomilla, chininum, sulphuricum, salicylicum acidum, silicea oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68703-212
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CARBON DISULFIDE (UNII: S54S8B99E8) (CARBON DISULFIDE - UNII:S54S8B99E8) CARBON DISULFIDE6 [hp_C]  in 30 mL
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE30 [hp_C]  in 30 mL
    HYDROQUININE SULFATE (UNII: F507371PJA) (HYDROQUININE - UNII:31J3Q51T6L) HYDROQUININE SULFATE6 [hp_C]  in 30 mL
    MAGNESIUM SALICYLATE (UNII: 41728CY7UX) (SALICYLIC ACID - UNII:O414PZ4LPZ) MAGNESIUM SALICYLATE6 [hp_C]  in 30 mL
    MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER) (MATRICARIA CHAMOMILLA FLOWERING TOP OIL - UNII:SA8AR2W4ER) MATRICARIA CHAMOMILLA FLOWERING TOP OIL6 [hp_C]  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    GRAPEFRUIT (UNII: O82C39RR8C)  
    LEMON OIL (UNII: I9GRO824LL)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    GINGER OIL (UNII: SAS9Z1SVUK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68703-212-3030 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product12/14/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/14/2016
    Labeler - Silver Star Brands (006070379)
    Registrant - Silver Star Brands (006070379)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vitality Works137752817manufacture(68703-212)
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