Label: GOYESCAS BRONCOVAC 5 SORE THROAT RELIEF- benzocaine liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 October 19, 2015

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  • Dosage & Administration

    Directions

    Adults and children 2 years of age and older, apply to affected area for at least one minute and then spit out. Use up to 4 times daily or as directed by doctor. Children under 12 years of age should be supervised in the used of the product. Children 2 years of age: Consult a doctor.

  • Warnings

    Warnings

    Keep away of reach from children. In case of overdose, get medical help or contact a Poison Control Center right away. Do not exceed recommended dosage. Stop use and ask a Doctor if: Sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea or vomiting, sore mouth symptoms do not improve in 7 days or if irritation, pain or redness persist or worsens. If pregnant or breast feeding, ask a health professional before use.

  • Inactive Ingredients

    Inactive ingredients

    Benzalkonium chloride, Eucalyptus oil, FD&C Red #40, Propylene Glycol, Purified Water, Sodium Bicarbonate, Sodium Borate and sorbitol

  • Uses

    Uses for the temporary relief of:

    Occasional minor irritation, pain, sore mouth and throat. Pain due to canker sores. Pain due to minor irritation of injury of the mouth and gums, minor discomfort and protection of irritated area in sore mouth and sore throat.

  • Purpose

    DRUG FACTS PURPOSE

    Benzocaine 5% Anesthetic

  • Warnings

    Warnings

    Keep away of reach from children. In case of overdose, get medical help or contact a Poison Control Center right away. Do not exceed recommended dosage. Stop use and ask a Doctor if: Sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea or vomiting, sore mouth symptoms do not improve in 7 days or if irritation, pain or redness persist or worsens. If pregnant or breast feeding, ask a health professional before use.

  • Active Ingredients

    DRUG FACTS

    ACTIVE INGREDIENTS PURPOSE

    Benzocaine 5% Anesthetic

  • PRINCIPAL DISPLAY PANEL

    DRUG FACTS

    ACTIVE INGREDIENTS PURPOSE

    Benzocaine 5% Anesthetic

    Uses for the temporary relief of:

    Occasional minor irritation, pain, sore mouth and throat. Pain due to canker sores. Pain due to minor irritation of injury of the mouth and gums, minor discomfort and protection of irritated area in sore mouth and sore throat.

    Warnings

    Keep away of reach from children. In case of overdose, get medical help or contact a Poison Control Center right away. Do not exceed recommended dosage. Stop use and ask a Doctor if: Sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea or vomiting, sore mouth symptoms do not improve in 7 days or if irritation, pain or redness persist or worsens. If pregnant or breast feeding, ask a health professional before use.

    Directions

    Adults and children 2 years of age and older, apply to affected area for at least one minute and then spit out. Use up to 4 times daily or as directed by doctor. Children under 12 years of age should be supervised in the used of the product. Children 2 years of age: Consult a doctor.

    Other Information

    Store at room temperature (68-77F) (20-25C)

    Do not freeze

    Alcohol Free

    Inactive ingredients

    Benzalkonium chloride, Eucalyptus oil, FD&C Red #40, Propylene Glycol, Purified Water, Sodium Bicarbonate, Sodium Borate and sorbitol.

    Carton

    Carton

    Label

  • INGREDIENTS AND APPEARANCE
    GOYESCAS BRONCOVAC 5  SORE THROAT RELIEF
    benzocaine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11856-5002
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    SORBITOL (UNII: 506T60A25R)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11856-5002-11 in 1 BOX
    133 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34610/01/2006
    Labeler - GOYESCAS OF FLA (032506248)