Label: ANAL GLIDE- benzocaine gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 August 8, 2016

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  • Drug FactsActive Ingredient

    Benzocaine 5%

  • Purpose

    Topical Analgesic

  • Keep out of reach of children

    Keep out of reach of children.

    If swallowed get medical help or contact a Poison Control Center right away.

  • Uses

    • For temporary relief of pain or soreness in the perianal area.
  • Warnings

    For external use only.

    • Avoid contact with eyes.
    • Certain persons can develop allergic reactions from ingredients in this product. If the symptom being treated goes not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use and consult a doctor.
  • Directions

    • When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly.
    • Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.
    • Apply to the affected area up to 6 times daily.
  • Other Information

    Do not use if safety seal is broken or missing.

  • Inactive Ingredients

    Hydroxyethylcellulose, Methylparaben, PEG-8, Propylene Glycol, Propylparaben, Water

  • anal GLIDE EXTRA product label

    anal GLIDE EXTRA

    Desensitizer Lubricating Gel

    PREMIUM

    Benzocaine Anorectal Gel

    Anal Desensitizer

    2 FL OZ (60 ml)

    www.bodyactionproducts.com

    Distributed by:

    Body Action Products

    Lutz, FL 33559

    ACTION BODY PRODUCTS

    PMG anal Glide

  • INGREDIENTS AND APPEARANCE
    ANAL GLIDE 
    benzocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70742-092
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE2833 mg  in 60 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70742-092-0160 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/15/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34806/15/2016
    Labeler - Product Max Group Inc (134893911)
    Registrant - Product Max Group Inc (134893911)
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