NENE DENTE- benzocaine liquid

Nene Dente by

Drug Labeling and Warnings

Nene Dente by is a Otc medication manufactured, distributed, or labeled by Menper Distributors, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                                Purpose

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

PURPOSE

Pain Reliever

INDICATIONS & USAGE

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

WARNINGS

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

Do not Use:

• for more than 7 days unless directed but a physician 
• if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics

STOP USE

Stop Use and see a Doctor

• if sore mouth symptoms do not improve in 7 days 
• if irritation, pain or redness persists or worsens
• if swelling, rash or fever develops

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

PREGNANCY OR BREAST FEEDING

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.

DOSAGE & ADMINISTRATION

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 SAFETY INFORMATION

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 INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NENE DENTE 
benzocaine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53145-335
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	2.1 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
MENTHOL (UNII: L7T10EIP3A)
METHYLPARABEN (UNII: A2I8C7HI9T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53145-335-01	1 in 1 CARTON
1		30 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	01/01/2014

Labeler - Menper Distributors, Inc (101947166)