MAKESENSE FIRST AID (LIDOCAINE HYDROCHLORIDE PHENOL) CREAM [CHERRY HILL SALES CO]

MAKESENSE FIRST AID (LIDOCAINE HYDROCHLORIDE PHENOL) CREAM [CHERRY HILL SALES CO]
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NDC 69020-210-28
Set ID 9b4666e0-d7c8-4b50-aa0c-c6a7b8e52617
Category HUMAN OTC DRUG LABEL
Packager Cherry Hill Sales Co
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART333E
  • 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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