Label: KO PINK PAIN RELIEF CREAM- lidocaine hcl and phenolate sodium cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 16, 2024

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  • Active Ingredients

    Lidocaine Hydrochloride 4.0%

    Phenolate Sodium 0.5%

  • Inactive Ingredients

    Water, Caprylic/Capric Triglyceride, Glycerin, Calendula Officinalis Flower Extract, Glyceryl Stearate, Sodium Hyaluronate, Butylene Glycol, Cetyl Alcohol, Sodium Hydroxide, Isonononyl Isononanoate, Stearic Acid, Thioctic Acid (Alpha Lipoic Acid) powder, Carbomer, Cetearyl 2-Ethylhexanoate, Dimethylsulfone (MSM), Polysorbate 80, Hydroxypropyl Methylcellulose, N-Acetyl Glucosamine, SYN-TC, Polysorbate 20, Palmitoyl Oligopeptide, Palmitoyl Tetrapeptide-7, Tocopheryl Acetate (Vitamin E), Phytonadione (Vitamin K), Benfotiamine, Curcumin, Ceramide 3, 3-glyceryl Ascorbate (Vitamin C), Pyridoxine Hydrochloride, Cyanocobalamin, Cyclodextrin, Caprylyl Glycol, Phenoxyethanol, Hexylene Glycol

  • Directions

    Adults and children over 18 years:

    • apply a thin layer to affected area and massage until thoroughly absorbed into the skin
    • apply every 6 to 8 hours, not to exceed 4 times daily
    • wash hands with soap and water before and after use

    Children 18 years or younger:

    • Ask a doctor
  • Use

    For the temporary relief of minor pain

  • Stop Use

    Stop use and ask a doctor if

    • condition worsens
    • if rash appears
    • symptoms persist for more than 7 days or clear up and occur again within a few days
  • Warning - Keep out of reach of children

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

  • Warnings

    For external use only

    Do not use:

    • In large quantities
    • Over raw surfaces or blistered areas
    • if you are allergic to ingredients in this product
    • on puncture wounds
    • Over large areas of the body

    When using this product:

    • use only as directed
    • do not bandage tightly or apply local heat (such as heating pads) to the area of use
    • avoid contact with eyes, lips and mouth
    • do not apply to wounds, damaged, broken or irritated skin
  • Storage

    store out of direct light at room temperature, between 40F and 86F (4C and 30C)

    do not use if protective seal on jar is torn broken or missing upon first use

  • Purpose

    For the relief of minor pain

  • Pregnant or Breastfeeding

    If pregnant or breast feeding:

    Ask a health professional before use

  • PRINCIPAL DISPLAY PANEL

    FrontDrug Facts

  • INGREDIENTS AND APPEARANCE
    KO PINK PAIN RELIEF CREAM 
    lidocaine hcl and phenolate sodium cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70317-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS0.04 g  in 1 mL
    PHENOLATE SODIUM (UNII: 4NC0T56V35) (PHENOL - UNII:339NCG44TV) PHENOLATE SODIUM0.005 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  
    CYCLODEXTRINS (UNII: 7E6SK9QDT8)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    THIOCTIC ACID (UNII: 73Y7P0K73Y)  
    N-ACETYLGLUCOSAMINE (UNII: V956696549)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    GLYCERYL 1-STEARATE (UNII: 258491E1RZ)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    CYANOCOBALAMIN (UNII: P6YC3EG204)  
    TETRADECYL AMINOBUTYROYLVALYLAMINOBUTYRIC UREA TRIFLUOROACETATE (UNII: 0UBP26S1LG)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
    BENFOTIAMINE (UNII: Y92OUS2H9B)  
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
    PALMITOYLLYSYLVALYLDIAMINOBUTYROYLTHREONINE (UNII: 1615WE9073)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PHYTONADIONE (UNII: A034SE7857)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    WATER (UNII: 059QF0KO0R)  
    CURCUMIN (UNII: IT942ZTH98)  
    3-GLYCERYL ASCORBATE (UNII: 3R1Q5X5GGO)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70317-005-01118 mL in 1 JAR; Type 0: Not a Combination Product09/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01709/01/2023
    Labeler - Remeverse (050186540)
    Registrant - Lexia LLC (015552120)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lexia LLC015552120manufacture(70317-005)
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