Label: ROLL-ON PAIN- lidocaine hydrochloride 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 July 23, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Lidocaine 4%

  • Purpose

    Topical Analgesic

  • Uses

    Temporarily relieves minor pain associated with:

    • arthritis
    • sprains
    • simple backache
    • bruises
    • muscle strains
    • cramps
  • Warnings

    For external use only

    When using this product

    • use only as directed
    • do not bandage tightly
    • avoid contact with eyes
    • do not apply to wounds or damaged skin
    • do not use in large quantities, particularly over raw surfaces or blistered areas.

    Stop use and ask a doctor if

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

    Keep out of reach of children

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

  • Directions

    • Adults and children 12 years of age and older: Apply to the affected area not more than 3 to 4 times daily.
    • Children under 12 years of age: Consult a doctor.
  • Inactive Ingredients

    Allantoin, Caprylic/Capric Triglyceride, Capsicum Annuum Fruit Powder, Calcium Disodium EDTA, Cannabis Sativa (Aerial) Extract Oil, Dimethicone, dl-alpha Tocopheryl Acetate, Ethyl Alcohol, Ethylhexylglycerin, Ethylhexyl Stearate, Fragrance, Glycerin, Phenoxyethanol, Polysorbate 80, Propanediol, Propylene Glycol, Purified Water, Simethicone, Sodium Polyacrylate, Trideceth-6, Vitis Vinifera (Grape) Seed Oil, Xanthan Gum.

  • SPL UNCLASSIFIED SECTION

    Distributed by: planetHEMP • Pittsburgh, PA

  • PRINCIPAL DISPLAY PANEL - 74 ML Bottle Label

    pH

    ROLL-ON PAIN CREAM

    4% LIDOCAINE
    WITH CBD FROM INDUSTRIAL HEMP

    PLANETHEMP
    74ML - 2.5 FL. OZ.

    PRINCIPAL DISPLAY PANEL - 74 ML Bottle Label
  • INGREDIENTS AND APPEARANCE
    ROLL-ON PAIN 
    lidocaine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78818-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS40 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Allantoin (UNII: 344S277G0Z)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PAPRIKA (UNII: X72Z47861V)  
    EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)  
    CANNABIS SATIVA FLOWERING TOP (UNII: 8X454SZ22D)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    ALCOHOL (UNII: 3K9958V90M)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    TRIDECETH-6 (UNII: 3T5PCR2H0C)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CARYOPHYLLENE (UNII: BHW853AU9H)  
    Product Characteristics
    ColorWHITE (Opaque) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78818-003-021 in 1 BOX07/08/2020
    174 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/08/2020
    Labeler - PlanetHEMP LLC (077256475)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ion Labs, Inc.106499791MANUFACTURE(78818-003)
    Establishment
    NameAddressID/FEIBusiness Operations
    PlanetHemp LLC077256475LABEL(78818-003)
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