Label: AFTER CUTS AND SCRAPES- lidocaine hydrochloride, benzalkonium chloride solution

  • 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 October 28, 2016

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

  • Active Ingredient

    Lidocaine Hydrochloride 2.5%

    Benzalkonium Chloride .13%

  • Purpose

    Anesthetic

    Antiseptic

  • Uses

    First aid for the temporary relief of pain and to protect from infection in minor cuts, scrapes and burns

  • Warnings

    For External Use Only

    When using this Product:

    • Do not get into eyes
    • Do not use in large quantities, particularly over raw surfaces or blistered areas

    Stop use and ask a doctor if:

    • rash, redness or swelling occurs or pain increases
    • in case of deep puncture wounds, animal bites or serious burns consult a doctor

    If swallowed, get medical help or contact a poison control center right away

    If in eyes flush with water for 15 minutes and call a doctor

  • Keep Out of Reach of Children

  • Directions

    Shake Well. Clean affected area. Spray on the area 1 to 3 times daily

    Adults and children 2 years and older apply to affected area

    Children under 2 years ask a doctor

  • Inactive Ingredients

    Aloe Vera Gel, Germaben II, Orange Blossom Fragrance, Polysorbate 20, Propylene Glycol, Purified Water and Sorbitol 70%

  • Package Label

    Family Medic

    After Cuts & Scrapes

    Topical Analgesic/Antiseptic

    First Aid Treatment Spray Formula

    Family Medic

    • Relieves pain from minor cuts, scrapes and burns
    • Helps prevent infecction

    For Cuts, Scrapes and Burns

    After Cuts & Scrapes

    Anesthetic, Antiseptic Spray

    Medicated First Aid Treatment with Aloe Vera

    Fast pain relief. Helps prevent infection & heal minor

    • cuts
    • burns
    • scrapes
    • irritations

    1 fl. Oz

    30mL

    Tender Corporation Littleton, NH 03561 Made in USA

    See a complete line of our products for the prevention and treatement of outdoor ailments at www.tendercorp.com

    After Cuts & Scrapes

  • INGREDIENTS AND APPEARANCE
    AFTER CUTS AND SCRAPES 
    lidocaine hydrochloride, benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44224-3300
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE26 mg  in 1 mL
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS25 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44224-3300-01 in 1 BOX07/11/2003
    130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/11/2003
    Labeler - Tender Corporation (064437304)
    Registrant - Tender Corporation (064437304)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tender Corporation064437304manufacture(44224-3300)