3X MEDICATED MOUTH SORE GEL- benzocaine gel

3x Medicated Mouth Sore Gel by

Drug Labeling and Warnings

3x Medicated Mouth Sore Gel by is a Otc medication manufactured, distributed, or labeled by HEB, Lornamead. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients Purpose

Benzocaine 20% . . . . . .Oral pain reliever

Menthol 0.1% . . . . . . . . Oral pain reliever

Zinc chloride 0.15% . . . .Oral astringent

WARNINGS

Methemoglobinemia warning: use of this product may cause methoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops: * pale, gray, or blue colored skin (cyanosis) * headache * rapid heart rate * shortness of breath * dizziness or lightheadedness * fatigue or lack of energy

Allergy alert

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

Do not use

• more than directed
• for more than 7 days unless directed by a dentist or doctor
• for teething
• in children under 2 years of age

Stop use and ask a doctor if

• sore mouth symptoms do not improve in 7 days
• swelling, rash or fever develops
• irritaiton, pain or redness persists or worsens

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

INACTIVE INGREDIENT

allantoin, carbomer, disodium EDTA, flavor, polyethylene glycol, polysorbate 60, propylene glycol, pvp, sodium saccharin, sorbic acid, stearyl alcohol, water

QUESTIONS

Questions and Comments? Call 1-877-7777-2743

PURPOSE

for the temporary relief of pain associated with canker sores, cold sores, fever blisters, minor irritation or injury of the mouth and gums

INDICATIONS & USAGE

Directions

• cut open tip of tube on score mark
• do not use if tip is cut prior to opening
• adults and children 2 years of age and older: apply to affected area up to 4 times daily or as directed by a dentist or doctor.
• Children between 2 and 12 years of age: ask a doctor before use. Should be supervised in the use of this product
• children under 2 years of age: do not use

DOSAGE & ADMINISTRATION

• cut open tip of tube on score mark
• do not use if tip is cut prior to opening
• adults and children 2 years of age and older: apply to affected area up to 4 times daily or as directed by a dentist or doctor.
• Children between 2 and 12 years of age: ask a doctor before use. Should be supervised in the use of this product
• children under 2 years of age: do not use

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

3X MEDICATED MOUTH SORE GEL 
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37808-691
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	0.1 g  in 100 g
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	20 g  in 100 g
ZINC CHLORIDE (UNII: 86Q357L16B) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.15 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
POLYSORBATE 60 (UNII: CAL22UVI4M)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
METHYL SALICYLATE (UNII: LAV5U5022Y)
POVIDONE K90 (UNII: RDH86HJV5Z)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)
SORBIC ACID (UNII: X045WJ989B)
ALLANTOIN (UNII: 344S277G0Z)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Product Characteristics
Color	yellow (Clear to yellow tint)	Score
Shape		Size
Flavor	WINTERGREEN	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37808-691-19	1 in 1 CARTON	06/02/2020
1		9.4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	06/02/2020

Labeler - HEB (007924756)

Registrant - Lornamead (119559733)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead		080046418	manufacture(37808-691)