Medication Guide App

Oral Pain Reliever

Dosage form: liquid
Ingredients: BENZOCAINE 20g in 100g
Labeler: Dolgencorp LLC
NDC Code: 55910-824

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 anesthetic

UseTemporarily relieves pain associated with the following mouth and gum irritations:
*toothache * sore gums * canker sores * braces * minor dental procedures

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 * avoid contact with eyes * do not exceed recommended dosage
* do not use for more than 7 days unless told to do so by a dentist or doctor

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

Center right away.

Directions *Adults and children 2 years of age and older:

*apply to affected area using applicator tip
*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 Informationstore at 20 - 25 C (68-77F)

Inactive ingredientsEthyl Alcohol 44.2% by weight,
FD C Blue 1, FD C Red 40, FD C
Yellow 5, Flavor, Polyethylene
glycol, Sodium Saccharin, Water




• 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
ORAL PAIN RELIEVER 
benzocaine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-824
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE20 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 40033.87 g  in 100 g
ALCOHOL44.2 g  in 100 g
SACCHARIN SODIUM0.5 g  in 100 g
FD&C RED NO. 400.55 g  in 100 g
FD&C YELLOW NO. 50.9 g  in 100 g
FD&C BLUE NO. 10.04 g  in 100 g
WATER0.6732 g  in 100 g
Product Characteristics
Colororange (orange to reddish orange) Score    
ShapeSize
FlavorMINT (N&A Mint Flavor 619179) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:55910-824-481 BOTTLE, WITH APPLICATOR (BOTTLE) in 1 BLISTER PACK
1NDC:55910-824-4114.17 g in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B01/10/2012
Labeler - Dolgencorp LLC (068331990)
Registrant - Lornamead (126440440)
Establishment
NameAddressID/FEIOperations
CSR Cosmetic Solutions243501959manufacture

Revised: 01/2012
 
Dolgencorp LLC

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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