Label: GENUINE FIRST AID PAIN RELIEVING CREAM- benzalkonium chloride, lidocaine hydrochloride cream

  • NDC Code(s): 50814-079-01
  • Packager: GFA Production (Xiamen) Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 22, 2024

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  • Drug Facts

  • Active Ingredients

    Benzalkonium Chloride 0.13%

    Lidocaine HCl 0.5%

    Purpose

    First Aid Antiseptic

    Topical Analgesic

  • Uses

    • Temporary relief of pain associated with minor cuts, scrapes, and burns.
    • Helps pretect against harmful bacteria.
  • Warnings

    For external use only.

    Do not use

    • in eyes • in large quantities • over raw or blistered areas, or on deep puncture wounds, animal bites, or serious burns • for more than one week unless directed by a doctor

    Keep out of the reach of children.

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

  • Directions

    • clean affected area
    • apply small amount not more than 3 times daily
    • may be covered with a sterile bandage
  • Other information

    • store in a cool dry area 15° to 25° C (59° to 79°F)
    • tamper evident sealed packets
    • do not use any opened or torn packets
  • Inactive ingredients

    Aloe Barbadensis Leaf Juice, Cetearyl Alcohol, Disodium EDTA, Ethylhexylglycerin, Glycerin, Glyceryl Stearate/PEG-100 Stearate, Maltodextrin, Mineral Oil, Phenoxyethanol, Propylene Glycol, Purified Water, Stearic Acid, Triethanolamine

  • Package Labeling:

    Label02

  • INGREDIENTS AND APPEARANCE
    GENUINE FIRST AID PAIN RELIEVING CREAM 
    benzalkonium chloride, lidocaine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50814-079
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 g
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50814-079-010.9 g in 1 TUBE; Type 0: Not a Combination Product11/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00311/01/2023
    Labeler - GFA Production (Xiamen) Co., Ltd. (421256261)
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