BABY ANESTENKA (BENZOCAINE) LIQUID [MENPER DISTRIBUTORS]

BABY ANESTENKA (BENZOCAINE) LIQUID [MENPER DISTRIBUTORS]
PDF | XML

NDC 53145-902-12
Set ID 89e1d50c-a33a-4911-839c-06527d30af2d
Category HUMAN OTC DRUG LABEL
Packager Menper Distributors
Generic Name
Product Class
Product Number
Application Number PART356
  • 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

    Baby Anestenka Label

  • INGREDIENTS AND APPEARANCE
    BABY ANESTENKA 
    benzocaine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53145-902
    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)  
    MENTHOL (UNII: L7T10EIP3A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53145-902-121 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 (101947166)

Related Drugs