Label: TOKISAN SORE THROAT RELIEF- benzocaine liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 11856-5001-1 - Packager: GOYESCAS OF FLA
- 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 October 19, 2015
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- Dose
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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
- Uses
- Purpose
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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 Ingredient
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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.
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INGREDIENTS AND APPEARANCE
TOKISAN SORE THROAT RELIEF
benzocaine liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11856-5001 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) EUCALYPTUS OIL (UNII: 2R04ONI662) FD&C RED NO. 40 (UNII: WZB9127XOA) WATER (UNII: 059QF0KO0R) SODIUM BICARBONATE (UNII: 8MDF5V39QO) SODIUM BORATE (UNII: 91MBZ8H3QO) SORBITOL (UNII: 506T60A25R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11856-5001-1 1 in 1 BOX 1 33 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 08/01/1958 Labeler - GOYESCAS OF FLA (032506248)