Label: TOPICAINE- lidocaine 4% 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 December 7, 2021

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  • Active ingredient

    Lidocaine 4% w/w

  • Purpose

    Topical Anesthetic

  • Uses

    For the temporary relief of pain.

  • Warnings

    For external use only

    Flammable

    Keep away from sparks, heat and fire. Cap tube tightly when not in use.

  • Stop use and ask a doctor if:

    • allergic reaction occurs
    • condition worsens or does not improve within 7 days
    • symptoms clear up and return within a few days
    • you notice any unusual effects
  • Keep out of the reach of children

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

  • Directions

    Apply externally to affected area up to 3 to 4 times a day. Children under 2 years of age consult a doctor.

  • Inactive Ingredients

    Aloe Barbadensis Leaf Extract, Benzyl Alcohol, Carbomer, Disodium EDTA, Glycerin, Glyceryl Laurate, SD Alcohol 40B, Simmondsia Chinensis (Jojoba) Seed Oil, Water

  • Questions

    Call toll-free in USA & Canada 800-677-9299 or visit www.topicaine.com

  • Labelling on tubes and outer cartons

    Labelling printed on tube of Topicaine 4% 10 gram tube:

    Printing on the tube of Topicaine 4% 10 g

    Outer carton of Topicaine 4% 10 grams:

    Box of Topicaine 4% 10 grams

    Label affixed to Topicaine 4% 30 gram tubes:

    Label affixed to tubes of Topicain 4% 30 grams

    Outer box of Topicaine 4% 30 grams:

    Box for Topicaine 4% 30 gram tubes

    Label affixed to tubes of Topicaine 4% 113 grams:

    Labels Topicaine 4% 113 gram tubes

  • INGREDIENTS AND APPEARANCE
    TOPICAINE 
    lidocaine 4% gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63135-312
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 44.534 g  in 100 g
    CARBOMER 940 (UNII: 4Q93RCW27E) 0.6 g  in 100 g
    ALCOHOL (UNII: 3K9958V90M) 36.842 g  in 100 g
    JOJOBA OIL (UNII: 724GKU717M) 2.5 g  in 100 g
    GLYCERYL LAURATE (UNII: Y98611C087) 2 g  in 100 g
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 2.5 g  in 100 g
    BENZYL ALCOHOL (UNII: LKG8494WBH) 2 g  in 100 g
    GLYCERIN (UNII: PDC6A3C0OX) 5 g  in 100 g
    EDETATE DISODIUM (UNII: 7FLD91C86K) 0.024 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63135-312-301 in 1 BOX04/20/2003
    130 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:63135-312-131 in 1 BOX04/20/2003
    210 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:63135-312-04113 g in 1 TUBE; Type 0: Not a Combination Product04/20/2003
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34604/20/2003
    Labeler - ESBA LABORATORIES INC. (963303490)
    Registrant - ESBA LABORATORIES INC. (963303490)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESBA LABORATORIES INC963303490manufacture(63135-312)
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