Label: HEMPVANA ULTRA STRENGTH PAIN RELIEF CREAM- lidocaine 4% cream

  • Category: HUMAN OTC DRUG LABEL

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 24, 2021

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  • Active Ingredient

    Lidocaine 4%

  • Purpose

    Lidocaine 4%..................Topical Analgesic

  • Uses

    For the temporary relief of minor aches and pains.

  • Warnings

    For external use only

    Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

    When using this product

    • Use only as directed. Read and follow all directions and warnings on this label.
    • Do not bandage tightly or apply local heat (such as heating pads) to the area of use.
    • Avoid contact with eyes or mucous membranes.
    • Do not apply to wounds or damaged, broken or irritated skin.
    • Do not use at the same time as other topical analgesics.

    Stop use and ask a doctor if

    • Condition worsens
    • Symptoms persist for more than 7 days or clear up and occur again within a few days
    • Redness is present or irritation develops

    If pregnant or breast-feeding, ask a health professional before use.

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

  • 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 physician
    • Apply generously to affected area.
    • Massage into painful area until thoroughly absorbed into skin.
    • Repeat as necessary, but no more than 4 times daily.
  • Inactive Ingredients

    Water/Aqua/Eau, Ethylhexyl Stearate, Butylene Glycol, Dimethicone, Stearic Acid, Caprylic/Capric Triglyceride, Cannabis Sativa (Hemp) Seed Oil, Glyceryl Stearate, PEG-100 Stearate, Cetearyl Alcohol, Helianthus Annuus (Sunflower) Seed Oil, Curcuma Longa (Turmeric) Root Extract, Allantoin, Glycerin, Tocopheryl Acetate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Sodium Hydroxide, Disodium EDTA, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Polysorbate 80, Blue 1 (CI 42090), Yellow 5 (CI 19140)

  • Questions?

    Questions? Call (855) 877-4503 (M-F, 9am-5pm EST)

  • PRINCIPAL DISPLAY PANEL

    Hempvana

    Ultra Strength

    Pain Relief

    Cream

    with 4% Lidocaine

    + Hemp Seed Oil

    Odor Free!

    Net Wt. 4 OZ (119 g)

    1

    2

  • INGREDIENTS AND APPEARANCE
    HEMPVANA ULTRA STRENGTH PAIN RELIEF CREAM 
    lidocaine 4% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73287-016
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    ALLANTOIN (UNII: 344S277G0Z)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    WATER (UNII: 059QF0KO0R)  
    ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    TURMERIC (UNII: 856YO1Z64F)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73287-016-011 in 1 CARTON05/24/2021
    1119 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 finalpart34805/24/2021
    Labeler - Telebrands Corp (177266558)
    Establishment
    NameAddressID/FEIBusiness Operations
    Neutraderm, Inc.146224444manufacture(73287-016)
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