MOUTH SORE RELIEF APPLICATOR- benzocaine liquid

Mouth Sore Relief Applicator by

Drug Labeling and Warnings

Mouth Sore Relief Applicator by is a Otc medication manufactured, distributed, or labeled by Swabplus Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PRINCIPAL DISPLAY PANEL

Image of carton label

INGREDIENTS AND APPEARANCE

MOUTH SORE RELIEF APPLICATOR 
benzocaine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65734-867
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	200 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
GLYCERIN (UNII: PDC6A3C0OX)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65734-867-24	3.6 mL in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	06/01/2005

Labeler - Swabplus Inc. (876441549)

Registrant - Swabplus Inc. (876441549)

Establishment
Name	Address	ID/FEI	Business Operations
Swabplus Inc.		876441549	manufacture(65734-867) , relabel(65734-867) , repack(65734-867)