3x Medicated Mouth Sore Gel: Package Insert and Label Information

3X MEDICATED MOUTH SORE GEL- zinc chloride, menthol, unspecified form and benzocaine gel
Walgreens

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.

Benzocaine 20%

Menthol 0.1%

Zinc chloride 0.15%

Oral pain reliever

Oral pain reliever

Oral astringent

temporarily relieves pain caused by * canker sores * cold sores * fever blisters * minor irritation or injury of the mouth and gums

Methemoglobinemia warning: use of this product may cause methemoglobinemia, 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: 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 told to do so by a dentist or doctor * for teething * in children under 2 years of age

Stop use and ask a doctor if * swelling, rash or fever develops * irritation, pain or redness persists or worsens * symptoms do not improve in 7 days * allergic reaction occurs

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

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 under 12 years of age should be supervised in the use of this product * children under 2 years of age: do not use

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

Carton Artwork
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3X MEDICATED MOUTH SORE GEL
benzocaine gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-1605
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC CHLORIDE (ZINC CATION) ZINC CATION 0.15 g in 100 g
MENTHOL, UNSPECIFIED FORM (MENTHOL, UNSPECIFIED FORM) MENTHOL, UNSPECIFIED FORM 0.1 g in 100 g
BENZOCAINE (BENZOCAINE) BENZOCAINE 20 g in 100 g
Inactive Ingredients
Ingredient Name Strength
STEARYL ALCOHOL
ALLANTOIN
WATER
EDETATE DISODIUM (EDETIC ACID)
POLYSORBATE 60
METHYL SALICYLATE
PROPYLENE GLYCOL
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)
POLYETHYLENE GLYCOL 400
POVIDONE K90
SORBIC ACID
SACCHARIN SODIUM (SACCHARIN)
Product Characteristics
Color yellow (Clear to yellow tint) Score
Shape Size
Flavor WINTERGREEN Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-1605-51 1 TUBE in 1 CARTON contains a TUBE
1 11.9 g in 1 TUBE This package is contained within the CARTON (0363-1605-51)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 07/01/2021
Labeler — Walgreens (008965063)
Registrant — Lornamead (080046418)
Establishment
Name Address ID/FEI Operations
Lornamead 080046418 manufacture (0363-1605)

Revised: 07/2021 Walgreens

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