Label: TOUGH LOVE PAIN RELIEVING- lidocaine hcl cream

  • NDC Code(s): 62742-4222-1, 62742-4222-2
  • Packager: Allure Labs Inc
  • 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 November 28, 2022

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredients

    Lidocaine HCL 4 %

  • PURPOSE

    Purpose

    Pain Reliver

  • INDICATIONS & USAGE

    Uses

    Temporarily relieves minor pain associated with Muscle strains,sprain and simple backache,insect bites.

  • WARNINGS

    Warnings

    For external use only

  • DO NOT USE

    Do not uses

    Do not apply to wounds or damaged skin

  • WHEN USING

    When using this Product use only as directed

    do not bandage tightly or use with a heating pad

  • STOP USE

    Stop uses

    Condition Worsens

    Symptoms persist for more than 7 days or clear up and occur again within a few days

    Redness is present

    Irritation develops

  • 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

    Direction

    Adults and children over 12 years of age

    apply externally to affected area up to 2-3 time a day.

    repeat as necessary, but no more than 4 time daily.

    children 12 year or younger ask a doctor

  • OTHER SAFETY INFORMATION

    Other safety information and warning

    Warning: For adults only. Consult your physician before use if you are pregnant, lactating, taking medications, or have a medical condition. Keep out of reach of children.

    Warning: Consuming this product can expose you to chemicals including lead, which is known to the State of California to cause birth defects or other reproductive harm. For more information go to www.p65warnings.ca.gov.

    These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

  • INACTIVE INGREDIENT

    Inactive Ingredient

    Water ((Aqua), Glyceryl stearate, Butyrospermum Parkii Nut Extract, glycerin, Ceteraryl Alcohol, Broad Spectrum Hemp Extract, Cetearyl Olivate, Aloe Barbadensis Leaf Juice, Caprylic/Capric Triglyceride, Sorbitan Olivate, stearic Acid, Candelilla/Jojoba/Rice Bran Polyglyceride-3Esters, Linum Usitatissimum(Linseed) Seed Oil, Sodium Phytate,Xanthan Gum, Hydroxyapatite, Citric Acid,Tocopherol,

    Persea Gratissima (Avocado) Oil,Sodium Stearoyl Lactylate,Viburnum Opulus Bark Extract, Alcohol,Glycyrrhiza Glabra (Licorice) Root Extract, Lavandula Angustifolia (Lavender)Oil,Cananga Odorata Flower Oil, Melia Azadirachta Flower Extract,Corallina Officinalis Extract,Cocconia Indica Fruit Extract,Melia Azadirachta Leaf extract,Solanum Melongena (Eggplant) Fruit Extract, Aloe Barbadensis Flower Extract,Ocimum Sanctum Leaf Extract,Curcuma Longa (Turmeric) Root Extract, Phenoxyethanol,Caprylyl Glycol,Ethylhexylglycerin, Hexylene Glycol

  • PRINCIPAL DISPLAY PANEL

    Toughlovepainrelieving

  • INGREDIENTS AND APPEARANCE
    TOUGH LOVE PAIN RELIEVING 
    lidocaine hcl cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4222
    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
    RICE BRAN (UNII: R60QEP13IC)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    YLANG-YLANG OIL (UNII: 8YOY78GNNX)  
    VIBURNUM OPULUS BARK (UNII: T1UG6H6805)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    SHEANUT (UNII: 84H6HBP32L)  
    LINSEED OIL (UNII: 84XB4DV00W)  
    PHYTATE SODIUM (UNII: 88496G1ERL)  
    SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    AZADIRACHTA INDICA LEAF (UNII: HKY915780T)  
    ALOE VERA FLOWER (UNII: 575DY8C1ER)  
    TURMERIC (UNII: 856YO1Z64F)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    EGGPLANT (UNII: W5K7RAS4VK)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    JOJOBA OIL GLYCERETH-8 ESTERS (UNII: 435WC6V33R)  
    AZADIRACHTA INDICA FLOWER (UNII: 3TE8A92UPM)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CORALLINA OFFICINALIS (UNII: 4004498D06)  
    COCCINIA GRANDIS FRUIT (UNII: VLJ6WOT3K5)  
    HOLY BASIL LEAF (UNII: SCJ765569P)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CANNABIDIOL (UNII: 19GBJ60SN5)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62742-4222-21 in 1 CARTON11/28/2022
    1NDC:62742-4222-150 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 finalpart34811/28/2022
    Labeler - Allure Labs Inc (926831603)
    Registrant - Allure Labs Inc (926831603)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allure Labs Inc926831603manufacture(62742-4222)