Label: ANESGERM- benzocaine gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 Label Information

Updated May 8, 2015

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredient                                       Purpose

    Benzocaine 20% .................................... Pain Reliever

  • PURPOSE

    Uses

    for the temporary relief of pain due to:

    • toothache
    • minor irritation or injury of the mouth and gums
    • infection cause by dentures or orthodontic appliances
    • sore gums due to teething in infants and children 4 months of age and older
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help immediately.

  • DOSAGE & ADMINISTRATION

    Directions

    children under 12 years of age should be supervised in the use of this product.  Adults and children 12 years of age and older:

    • apply to the affected area up to 4 times a day or as directed by a dentist or doctor

    Children under 2 years of age:

    • consult a dentist or doctor

    Teething Infants 4 months of age and over:

    • apply to the affected area up to 4 times daily or as directed by a dentist or doctor

    Infants under 4 months of age:

    • consult a dentist or doctor
  • INDICATIONS & USAGE

    GERMA

    Anesterm

    Maximum Strength Oral Pain Reliever

    20% Benzocaine PLUS Oil of Cloves

    Fast Pain Relief

    Easy To Apply

    • Toothache
    • Sore Gums
    • Teething
    • Denture Irritation
    • Braces Irritation
  • WARNINGS

    Warnings

    Do not exceed recommended dosage.

    Do not use

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

    Stop use and ask a doctor if

    • sore mouth symptoms do not improve in 7 days
    • infection, pain, or redness persists or worsens
    • swelling, rash or fever develops
    • fever & nasal congestion are present in teething infants 4 months of age and over

    These symptoms may be a sign of infection or a serious condition.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    polyethylene glycol-75, polyethylene glycol-8, glycerin, propyl paraben, methyl paraben, sodium saccharin, clove oil

  • PRINCIPAL DISPLAY PANEL

    label image

  • INGREDIENTS AND APPEARANCE
    ANESGERM 
    benzocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10095-001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE0.2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    CLOVE OIL (UNII: 578389D6D0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10095-001-010.5 g in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35604/30/2015
    Labeler - World Perfumes, Inc (101312044)
    Establishment
    NameAddressID/FEIBusiness Operations
    World Perfumes, Inc101312044manufacture(10095-001)