Label: LIDOCAINE cream

  • NDC Code(s): 58980-824-30
  • Packager: Stratus Pharmaceuticals Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 18, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Lidocaine 4% (4g in 100g)

  • Purpose

    Local analgesic

  • Uses

    for the temporary relief of pain and itching associated with

    • minor burns
    • sunburn
    • minor cuts
    • scrapes
    • insect bites
    • minor skin irritations
  • Warnings

    For external use only

    When using this product

    • avoid contact with the eyes
    • do not use in large quantities, particularly over raw surfaces or blistered areas

    Stop use and consult a doctor if

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few days

    Lidocaine is NOT approved by FDA to treat teething pain and should NOT be given to infants and young children for this use.

    If pregnant or breast-feeding

    Ask a health professional before use.

    Keep out of reach of children. If accidentally ingested, get medical help or contact a Poison Control Center immediately.

  • Directions

    • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
    • Children under 2 years of age: do not use, consult a doctor.
  • Other information

    Store at 20°C to 25°C (68°F to 77°F)

  • Inactive ingredients

    acrylamide, allantoin, aloe vera extract, benzyl alcohol, c12-15 alkyl benzoate, carbomer, isohexadecane, polysorbate 80, propylene glycol, purified water, sodium acryloydimethyl taurate, sodium laureth sulfate, soy lecithin, tocopheryl acetate.

  • Questions?

    Call us at (800) 442-7882

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Stratus Pharmaceuticals Inc.
    Miami, FL 33186

  • PRINCIPAL DISPLAY PANEL - 28.35 g Tube Box

    STRATUS
    PHARMACEUTICALS INC

    NDC 58980-824-30

    Net WT. 1 oz. / 28.35 g

    LIDOCAINE CREAM
    4%

    PAIN RELIEVING CREAM

    FOR EXTERNAL USE ONLY.
    NOT FOR OPHTHALMIC USE

    PRINCIPAL DISPLAY PANEL - 28.35 g Tube Box
  • INGREDIENTS AND APPEARANCE
    LIDOCAINE 
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58980-824
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Lidocaine (UNII: 98PI200987) (Lidocaine - UNII:98PI200987) Lidocaine40 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Acrylamide (UNII: 20R035KLCI)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    Allantoin (UNII: 344S277G0Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Benzyl Alcohol (UNII: LKG8494WBH)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    Polysorbate 80 (UNII: 6OZP39ZG8H)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM ACRYLOYLDIMETHYLTAURATE (UNII: 2T9Q6EKI0G)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58980-824-301 in 1 BOX02/15/2024
    128.35 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM01702/15/2024
    Labeler - Stratus Pharmaceuticals Inc (789001641)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tarmac Products Inc059890491MANUFACTURE(58980-824)
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