Label: RESTORE LIDOCAINE PAIN RELIEF CREAM- lidocaine 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 May 5, 2021

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  • STATEMENT OF IDENTITY

    Restore By Pure Research LIDOCAINE PAIN RELIEF CREAM

  • ACTIVE INGREDIENT

    Lidocaine HCl 4%

  • PURPOSE

    Purpose

    Topical anesthetic

  • INDICATIONS & USAGE

    Uses: to reduce pain or discomfort caused by skin irritations such as sunburn, insect bites, poison ivy, poison oak, poison sumac, and minor cuts, scratches or burns.

  • WARNINGS

    For External Use only

  • WHEN USING

    When using this product, do not use in or near the eyes

    • do not use in large quantities, particularly over raw surfaces or blistered areas.
  • STOP USE

    Stop Use and ask a doctor if:

    • allergic reaction occurs
    • condition worsens or does not improve within 7 days
    • symptoms clear up and return within a few days
    • redness, irritation, swelling, pain or other symptoms begin.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions: adults and children 2 years and older apply externally to the affected area up to 3 to 4 times a day

    Children under 2 years, ask a doctor

  • OTHER SAFETY INFORMATION

    May be applied under occlusive dressing

    Store at 20 - 25° C

  • QUESTIONS

    support@restoriden.com

  • INACTIVE INGREDIENT

    Arnica Montana Extract, Capryl Glycol, Caprylic/Capric Triglycerides, Cetearyl Alcohol, Deionized Water, Emulsifying Wax NF, Ethylhexylglycerin, Glycerin,Hexylene Glycol, Hippophae Rhamnoides Fruit and Seed Oils, Phenoxyethanol, Polysorbate 20, Propylene Glycol, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Hydroxide, Stearic Acid, Tetrasodium EDTA, Tocopherol

  • PRINCIPAL DISPLAY PANEL

    RESTORE JAR LABEL AND

    RESTORE BOX

    RESTORE BOX ART

    RESTORE JAR LABEL

  • INGREDIENTS AND APPEARANCE
    RESTORE LIDOCAINE PAIN RELIEF CREAM 
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-605
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS2.24 g  in 56 g
    Inactive Ingredients
    Ingredient NameStrength
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)  
    WATER (UNII: 059QF0KO0R)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    JOJOBA OIL (UNII: 724GKU717M)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76348-605-011 in 1 BOX05/05/2021
    1NDC:76348-605-0256 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/05/2021
    Labeler - RENU LABORATORIES, INC. (945739449)
    Establishment
    NameAddressID/FEIBusiness Operations
    RENU LABORATORIES, INC.945739449manufacture(76348-605)
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