Label: LID O CREME ROLL ON- lidocaine hcl, menthol 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 31, 2018

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  • DRUG FACTS

  • Active ingredients and Purpose

    Active ingredientsPurpose
    Lidocaine HCL 4%............................Topical analgesic
    Menthol 1%.......................................Topical analgesic

  • Use

    For the temporary relief of pain.

  • Warnings

    For external use only. Avoid contact with the eyes.

    Do not use

    in large quantities, particularly over raw surfaces, or blistered areas.

    Stop use and ask a doctor if

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

    If pregnant or breast feeding,

    ask a health professional before use.

    Keep out of reach of children.

    If swallowed, 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: consult a doctor

  • Other information

    ▪ store in a cool dry place between (59-86°F)15-30°C

    ▪ don’t use if seal over cap is broken, torn, or missing

  • Inactive ingredients

    aloe vera leaf, alpha-tocopherol, arnica montana flower, caprylhydroxamic acid, caprylyl glycol, cyclomethicone 5, dimethicone, dimethyl sulfone, glycerin, glyceryl monostearate, glycol stearate, methylpropanediol, PEG-100 stearate, PEG/PPG-18/18-dimethicone, phenoxyethanol, sodium lauryl sulfate, sodium polyacrylate, stearyl alcohol, sweet almond oil, trideceth-6, water

  • Questions or comments?

    +1-305-231-8977 (M-F) 9 A.M. - 5 P.M. EST or www.pharmanatural.com

  • Manufactured & Distributed by:

    Pharma Natural, Inc.

    Hialeah, FL 33016

  • Principal Display Panel

    PAIN RELIEVING

    Pharma Natural

    Natural Health Solutions

    Lid O Creme

    Maximum Strength

    Topical Analgesic Cream

    Roll-On

    LIDOCAINE HCL 4%

    MENTHOL 1%

    2.5 oz. (71 g)

    LIDOCREME_LABEL

  • INGREDIENTS AND APPEARANCE
    LID O CREME ROLL ON 
    lidocaine hcl, menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63788-111
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    TRIDECETH-6 (UNII: 3T5PCR2H0C)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63788-111-2571 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product06/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/01/2018
    Labeler - Pharma Natural, Inc. (138059287)
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