NENE DENTE- benzocaine liquid 
Menper Distributors, Inc

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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Active ingredient                                Purpose

Benzocaine 7%..................................... Pain Reliever

Pain Reliever

Uses For the temporary relief of sore gums due to teething in infants and children 4 months of age and older.

Warnings: Do not exceed recommended dosage.

Keep this and all drugs out of the reach of children. Fever and nasal congestion are not symptoms of teething and may indicate the presence of infection. If these symptoms persist, consult your physician.

Do not Use:

Stop Use and see a Doctor

Keep out of reach of children.

If pregnant or  breast-feeding, ask a health professional before use. In case of accidental ingestion, get medical help or contact a Posion Control Center right away.

Directions: wash hands. Remove imprinted safety seal from bottle. Use your fingertip or cotto swab to apply 2-4 drops. Apply to affected area not more than four times daily or as directed by a physician. For infants under 4 months of age, ther is no recommended dosage or treatment execpt under the advice and supervision of a dentist or physician.

Other information: Store this product between 15-30 C (59-86 F). Do not use if printed plastic bottle wrap is broken, toen or missing prior to opening. Save outer carton for full directions and warnings.

Inactive ingredients: Cherry flavor, Glycerin, Propylene Glycol, Propylparaben, Menthol, Methylparaben.

Nene Dente Label

NENE DENTE 
benzocaine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53145-335
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE2.1 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
MENTHOL (UNII: L7T10EIP3A)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53145-335-011 in 1 CARTON
130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/01/2014
Labeler - Menper Distributors, Inc (101947166)

Revised: 1/2015
Document Id: ccac2d80-0d85-4154-8a92-8806fa1e6569
Set id: 6c79ba69-82d4-40d6-aa60-3e21f30dae6a
Version: 1
Effective Time: 20150123
 
Menper Distributors, Inc