TOKISAN SORE THROAT RELIEF- benzocaine liquid 
GOYESCAS OF FLA

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.

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Dose

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 Ingredient

DRUG FACTS

ACTIVE INGREDIENTS PURPOSE

Benzocaine 5% Anesthetic

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

Label

TOKISAN  SORE THROAT RELIEF
benzocaine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11856-5001
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
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11856-5001-11 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 finalpart34608/01/1958
Labeler - GOYESCAS OF FLA (032506248)

Revised: 10/2015
Document Id: 227e7e75-3e7f-5ec3-e054-00144ff8d46c
Set id: 227e7e75-3e7e-5ec3-e054-00144ff8d46c
Version: 1
Effective Time: 20151019
 
GOYESCAS OF FLA