Walgreens Severe Oral Pain Reliever

Dosage form: liquid
Ingredients: BENZOCAINE 20g in 100g
Labeler: Walgreens
NDC Code: 0363-5335

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 ingredient

Benzocaine 20.0%  ...................................................................... Oral anesthetic / analgesic

Use

for 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.

Directions

to 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

• 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

Other Information

do 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 ingredients

Benzyl 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.



Bottle


Blister

WALGREENS  SEVERE ORAL PAIN RELIEVER
benzocaine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-5335
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE20 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
MENTHOL 
ALCOHOL 
ETHYLCELLULOSES 
TANNIC ACID 
CETYLPYRIDINIUM CHLORIDE 
SUCRALOSE 
BENZYL ALCOHOL 
PROPYLENE GLYCOL 
OLETH-10 
DIMETHYL ISOSORBIDE 
RICINUS COMMUNIS SEED 
WATER 
POLYETHYLENE GLYCOL 300 
BENZOIN 
Product Characteristics
Coloryellow (orange to reddish orange) Score    
ShapeSize
FlavorMINT (Mint Flavor #25797) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0363-5335-511 BOTTLE, WITH APPLICATOR (BOTTLE) in 1 BLISTER PACK
1NDC:0363-5335-5814.17 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(0363-5335), pack(0363-5335)

Revised: 08/2013
 
Walgreens

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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