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Severe Oral Pain Reliever by Walgreens

Medically reviewed on January 9, 2018

Dosage form: liquid
Ingredients: BENZOCAINE 20g in 100g
Labeler: Walgreens
NDC Code: 0363-0838

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.

Drug Facts

Active ingredientBenzocaine 20.0%  ...................................................................... Oral pain reliever

Usefor the temporary relief of pain due to canker sores, minor irritation of the mouth and
gums caused by dentures or orthodontic appliances, or minor injury of the mouth or gums

For oral use only

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 Do not use for more than 7 days unless told to do so by a dentist or doctor
If sore mouth symptoms do not improve in 7 days; if irritation, pain or redness persists or worsens;
or, if swelling, rash or fever develops, see your doctor or dentist promptly. Do not exceed
recommended dosage.

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

Center right away.

Directionsto assure formation of long lasting film coating, dry affected area and apply
medication undiluted with applicator. allow a few seconds for coating to form. use up to 4 times
daily, or as directed by a dentist or doctor. children 12 years of age should be supervised in
the use of this product. children under 2 years of age:ask a dentist or doctor

Other Informationdo not purchase if package has been opened
store at 20 - 25 C (68-77F)
close cap tightly after use to avoid evaporation
avoid contact with eyes
avoid contact with clothing and household furniture surfaces to avoid possible staining
this is a personal care item, and should be used by one individual only

Inactive ingredientsBenzyl Alcohol, Cetylpyridinium
Chloride, Compound Benzoin Tincture,
Dimethyl Isosorbide, Ethylcellulose,
Flavor, Octylacrylamideacrylates/
butylaminoethyl/methacrylate
Copolymer, Oleth-10, PEG-6, Propylene
Glycol, Ricinus Communis (Castor)
Seed Oil, SD Alcohol 38B, Sucralose,
Tannic Acid.





• use 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: consult a dentist or doctor
SEVERE ORAL PAIN RELIEVER 
benzocaine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0838
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE20 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
MENTHOL0.434 g  in 100 g
ALCOHOL28.0876 g  in 100 g
ETHYLCELLULOSES0.01 g  in 100 g
TANNIC ACID3.0 g  in 100 g
CETYLPYRIDINIUM CHLORIDE0.05 g  in 100 g
SUCRALOSE0.3 g  in 100 g
BENZYL ALCOHOL0.1 g  in 100 g
PROPYLENE GLYCOL5.0 g  in 100 g
OLETH-100.5 g  in 100 g
DIMETHYL ISOSORBIDE0.5 g  in 100 g
RICINUS COMMUNIS SEED0.2 g  in 100 g
WATER1.4783 g  in 100 g
POLYETHYLENE GLYCOL 30033.85 g  in 100 g
BENZOIN1.0 g  in 100 g
Product Characteristics
Coloryellow (orange to reddish orange) Score    
ShapeSize
FlavorMINT (Mint Flavor #25797) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0363-0838-511 BOTTLE, WITH APPLICATOR (BOTTLE) in 1 BLISTER PACK
1NDC:0363-0838-5814.17 g in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B01/10/2012
Labeler - Walgreens (008965063)
Registrant - Lornamead (126440440)
Establishment
NameAddressID/FEIOperations
CSR Cosmetic Solutions243501959manufacture

 
Walgreens

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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