Label: NBE- zinc gluconate and zinc acetate spray, metered

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated August 31, 2010

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Zincum Aceticum 2XReduces duration and
    severity of the common cold
    Zincum Gluconicum 1X
  • Uses

    • Reduces duration of the common cold
    • Reduces severity of cold symptoms:
      • Sneezing
      • Sore Throat
      • Stuffy Nose
      • Coughing
      • Congestion
  • Warnings

    For oral use only, not for use in nasal pathways.

    When using this product

    • Avoid contact with eyes. In case of accidental contact with eyes, flush with water and immediately seek professional help.
    • Stop use and ask doctor if
    • Side effects occur. You may report side effects to FDA at 1-800-FDA-1088.

    Rite Aid® Pharmacy Cold Relief Oral Mist was formulated to shorten the duration of the common cold and may not be effective for flu or allergies.

    Stop use and ask a doctor if symptoms persist or if accompanied by fever.

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.

  • Directions

    • For best results, use at the first sign of a cold and continue to use for an additional 48 hours after symptoms subside.
    • Adults and children 3 years of age and older:
      • Remove protective over-cap.
      • Spray 4 - 5 times into mouth at the onset of symptoms.
      • Spray on inside of cheeks, roof of mouth and gums. Retain for 15 seconds. Swallow.
      • Repeat every three hours until symptoms are gone.
      • To avoid minor stomach upset, do not take on an empty stomach.
      • Do not eat or drink for 15 minutes after use. Do not eat or drink citrus fruits or juices for 30 minutes before or after use. Otherwise, drink plenty of fluids.
    • Children under 3 years of age:
      • Consult a doctor before use.
  • Inactive Ingredients

    Glycerin, Peppermint Flavor, Potassium Sorbate, Purified Water, Sucralose

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY: RITE AID
    30 HUNTER LANE, CAMP HILL, PA 17011

  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

    RITE
    AID®
    PHARMACY

    *Compare to the active ingredients
    in Zicam® Oral Mist Cold Remedy

    cold relief
    oral spray

    zincum aceticum, zincum gluconicum

    MINT FLAVOR

    shortens the duration and
    severity of the common cold

    use at the first sign
    of a cold

    non-drowsy

    no metallic aftertaste

    HOMEOPATHIC

    1.0 FL OZ/30mL

    Principal Display Panel – 30 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    NBE 
    zinc gluconate and zinc acetate spray, metered
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64762-871
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC - UNII:J41CSQ7QDS) ZINC GLUCONATE12.26 mg  in 1 mL
    ZINC ACETATE (UNII: FM5526K07A) (ZINC - UNII:J41CSQ7QDS) ZINC ACETATE0.46 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Glycerin (UNII: PDC6A3C0OX)  
    Potassium Sorbate (UNII: 1VPU26JZZ4)  
    Water (UNII: 059QF0KO0R)  
    Sucralose (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorPEPPERMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64762-871-301 in 1 CARTON
    130 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34709/30/2010
    Labeler - Dynamic Pharmaceuticals Inc. (617660712)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dynamic Pharmaceuticals Inc.617660712MANUFACTURE