MOUTH SORE RELIEF APPLICATOR- benzocaine liquid 
Swabplus Inc.

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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Mouth Sore Relief Applicator

Drug fact

Active Ingredient

Benzocaine 20%

Purpose

Pain Reliever

Uses

temporarily relieves these symptoms. cold sores. scanker sores. fever blisters. minor irritation or injury of the mouth and gums.

Warning Allergy Alert

Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics.

When using this product

avoid eye contact. do not exceed recommended dosage. do not use more than 7 days unless told to do so by a dentist or doctor.

Stop use and ask a doctor if

swelling. rash or fever develops, irritation, pain, or redness persists or worsen.

Do not use on children under 2 years except underteh advice and supervision of a doctor.

Keep out of the reach of children

if swallowed get medical help or contact a Poison Contro;mCenter right away.

Directions

Snap the tip at the color ring. Allow formula to flow down to the opposite tip. Apply formula with the saturated tip to affected area

Other Information

Avoid storaging at excessive heat.

Inactive Ingredient

Polyethylene glycol 400 (PEG-8), Glycerin, Saccharin sodium, water, pina Colada

Image of carton label

Image of mouth sore label

MOUTH SORE RELIEF APPLICATOR 
benzocaine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65734-867
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
GLYCERIN (UNII: PDC6A3C0OX)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65734-867-243.6 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B06/01/2005
Labeler - Swabplus Inc. (876441549)
Registrant - Swabplus Inc. (876441549)
Establishment
NameAddressID/FEIBusiness Operations
Swabplus Inc.876441549manufacture(65734-867) , relabel(65734-867) , repack(65734-867)

Revised: 2/2013
Document Id: 76bd4316-2ca7-4e6d-a63c-d8a51b2ae6e0
Set id: e44683ca-a4dd-4e03-a564-ba3edab532cd
Version: 2
Effective Time: 20130214
 
Swabplus Inc.