BABY ANESTENKA- benzocaine liquid

Baby Anestenka by

Drug Labeling and Warnings

Baby Anestenka by is a Otc medication manufactured, distributed, or labeled by Menper Distributors. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient                                      Purpose

Benzocaine 7%(w/w)...................................Oral Anesthetic/Analgesic

SPL UNCLASSIFIED SECTION

PURPOSE

Oral Anesthetic/Analgesic

INDICATIONS & USAGE

Uses temporarily relieves sore gums due to teething ininfants and children 4 months of age and older.

WARNINGS

For  oral use only.

Allery Alert: do not use tihs product if you have a history of allergy to local anesthetics such as procaine, butaine, benzocaine or other "caine" anesthetics.

Fever and nasal congestion are not symptoms of teething and may indicate the presence of infection. If these symptoms persist, consult your doctor or dentist. A fever could be a sign of serious condition.

DO NOT USE

Stop use and ask a doctor or dentist if 

• oral pain does not get better in 7 days
• irritation, pain, or redness does not go away
• rash or fever develops
• redness or swelling is present

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of accidental oveerdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions Do not use more than directed. Wash hands. Remov imprinted safety seal from bottle. Use your fingertip or cotton swab to apply 2-4 drops. Apply to affected area not more than four tims daily or as directed by a physician. For infants under 4 months of age, there is no recommended dosage or treatment execpt under the advice and supervision of a dentist or physican.

OTHER SAFETY INFORMATION

Other information Store at a controlled room temperature between 15 an 30 c (59-86 F)

Tamper Evident Feature: do not use if imprinted safety seal over bottle cap is torn, broken or missing prior to opening. Save outer carton for full instructions and warnings.

QUESTIONS

Questions? 1-800-560-5223 M-F 9 AM to 4 PM Eastern.

INACTIVE INGREDIENT

Inactive ingredients Cherry Flavor, Glycerin, Menthol, Methylparaben, Propylene Glycol, Propylparaben.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BABY ANESTENKA 
benzocaine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53145-902
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)
MENTHOL (UNII: L7T10EIP3A)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53145-902-12	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 (101947166)