Label: ABSORBINE JR. LIDOCAINE- lidocaine patch

  • 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 November 4, 2016

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  • ACTIVE INGREDIENT

    Active ingredientPurpose
    Lidocaine 4%Topical Analgesic
  • INDICATIONS & USAGE

    Uses  for the temporary relief of pain

  • Warnings

    For external use only

  • Do not use

    • on a large area of body with multiple patches, particularly over raw or blistered areas
    • on wounds or damaged skin
  • Ask a doctor before use if you have

    • redness over affected area
  • When using this product

    • avoid contact with eyes and mucous membranes
    • do not bandage tightly
  • Stop use and ask a doctor if

    • condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days
    • excessive skin irritation occurs
  • 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.

  • Directions

    • adults and children 12 years of age and older apply to the affected area no more than 3 to 4 times daily
    • cut open pouch and remove patch
    • stretch & peel off protective film and apply sticky side to affected area
    • children under 12 years of age consult a doctor
  • Other information

    • store at room temperature below 80ºF (27º C)
  • INACTIVE INGREDIENT

    Inactive ingredients   dihydroxyaluminum aminoacetate, edetate disodium, glycerin, kaolin, methylparaben, polyacrylic acid, polyvinyl alcohol solution, propylene glycol, propylparaben, purified water, sodium carboxymethylcellulose, sodium polyacrylate, sodium polyacrylate starch, sorbitol solution, tartaric acid, urea 

  • QUESTIONS

    Questions? Call 1-844-922-7672

  • Principal Display Panel

    NEW!

    Maximum Strength Lidocaine

    ABSORBINE jr.® PLUS

    Lidocaine Patch
    Maximum Strength 4% Lidocaine

    Targeted Pain Relief Numbs Away Pain

    • Odor Free
    • Fast Acting
    • Deep Penetrating
    • Comfortable, Breathable & Stays on Securely

    For Shoulders, Arms, Neck and Legs
    1 Large Medicated Patch 5 ½ x 4 in (14 x 10 cm)

    Our Max Strength Lidocaine Patch provides targeted pain relief for shoulders, arms, neck and legs. It's fast acting, deep penetrating and stays securely in place. Its an effective, safe and convenient way to get fast relief.

    FOR EASY REMOVAL OF PROTECTIVE FILM
    Pull
    Stretch
    Peel
    Apply

    • Deep Penetrating. No mess
    • Comfortable, Breathable & Stays on Securely
    • Soft, Flexible, and Will Not Stain
    • Wear Underneath Clothing without Detection
    • Can Cut to Desired Size
    Distributed by: Clarion Brands, LLC
    27070 Miles Rd., Suite A, Solon, OH 44139     Made in Taiwan
    PR-130512USAA      ©2016      www.absorbinejr.com

    LOT:

    EXP:

    package
  • INGREDIENTS AND APPEARANCE
    ABSORBINE JR. LIDOCAINE  
    lidocaine patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69693-414
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Lidocaine (UNII: 98PI200987) (Lidocaine - UNII:98PI200987) Lidocaine246 mg
    Inactive Ingredients
    Ingredient NameStrength
    Dihydroxyaluminum Aminoacetate (UNII: DO250MG0W6)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Glycerin (UNII: PDC6A3C0OX)  
    Kaolin (UNII: 24H4NWX5CO)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Polyvinyl Alcohol, Unspecified (UNII: 532B59J990)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Water (UNII: 059QF0KO0R)  
    Carboxymethylcellulose Sodium (UNII: K679OBS311)  
    Sorbitol (UNII: 506T60A25R)  
    Tartaric Acid (UNII: W4888I119H)  
    Urea (UNII: 8W8T17847W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69693-414-011 in 1 CARTON01/01/2017
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/01/2017
    Labeler - Clarion Brands, LLC (079742703)
    Establishment
    NameAddressID/FEIBusiness Operations
    TEH SENG PHARMACEUTICAL MFG. CO., LTD. 3RD PLANT658873318manufacture(69693-414)
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