Label: MAKESENSE FIRST AID- lidocaine hydrochloride phenol cream

  • 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 August 7, 2014

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  • Active ingredients

    Lidocaine HCl 0.5%

    Phenol 0.5%

  • Purpose

    Topical Analgesic

    Antiseptic

  • Uses

    ■ for the temporary relief of pain associated with minor cuts, scrapes or minor burns ■ first aid to help prevent the risk of skin infection in minor cuts, scrapes or minor burns

  • Warnings

    For external use only

  • Do not use

    ■ in eyes ■ over large areas of the body ■ with a bandage

  • Stop use and consult a doctor if

    ■ in cases of deep or puncture wounds, animal bites or serious burns ■ if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product ■ if redness, irritation, swelling, pain or other symptoms develop or increase

  • Keep out of reach of children

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

  • Directions

    ■ Cleanse affected area ■ Apply a small amount of this product (an amount equal to the surface of a finger) on the area 1 to 3 times daily

  • Other Information

    ■ store at room temperature 59 to 86F (15 to 30C) ■ see carton or tube crimp for lot number and expiration date

  • Inactive ingredients

    Cetearyl Alcohol, Glyceryl Stearate, Methylparaben, Mineral Oil, Petrolatum, Polysorbate 60, Propylene Glycol, Propylparaben, Purified Water, Sorbitan Stearate, Stearic Acid

  • Package Label

    image description

  • INGREDIENTS AND APPEARANCE
    MAKESENSE  FIRST AID
    lidocaine hydrochloride phenol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69020-210
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE ANHYDROUS (UNII: EC2CNF7XFP) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS0.5 g  in 100 g
    PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69020-210-2828 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/31/2014
    Labeler - Cherry Hill Sales Co (145959768)
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