NBE ANBESOL- 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.

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5820622 Walgreens NBE Anbesol Gel

Benzocaine 20%

Oral anesthetic

temporarily relieves pain associated with mouth and gum irritations

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.

to open tube, cut tip of tube on score mark * adults and children 2 years of age and older: apply to affected area up to 4 times daily or as directed by a dentist/doctor * children under 12 years of age: adult supervision should be given in the use of this product * children under 2 years of age: do not use * for denture irritation apply a thin layer to the affected area; do not reinsert dental work until irritation/pain is relieved; rinse mouth well after reinserting

store at 20-25C (68-77F). Do not refrigerate.

blue 1, carbomer, flavor, glycerin, polyethylene glycol, propylene glycol, red 40, sodium saccharin, sorbic acid, water, yellow 10

Carton R1

NBE ANBESOL 
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0316
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SORBIC ACID (UNII: X045WJ989B)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
GLYCERIN (UNII: PDC6A3C0OX)  
Product Characteristics
Colorred (Reddish-orange to slightly brown) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-0316-691 in 1 CARTON06/22/2022
19 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35604/30/2022
Labeler - Walgreens (008965063)
Registrant - Lornamead (080046418)
Establishment
NameAddressID/FEIBusiness Operations
Lornamead080046418manufacture(0363-0316) , pack(0363-0316)

Revised: 1/2023
Document Id: f214f16a-9fbf-845f-e053-2995a90a13e0
Set id: dd2a3125-32f8-5fff-e053-2995a90ac720
Version: 3
Effective Time: 20230112
 
Walgreens