Label: SUNHEAL TATTOO NUMBING CREAM cream

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

Drug Label Information

Updated December 19, 2023

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

  • Active Ingredient

    Lidocaine 5%

  • Purpose

    For the temporary relief of local itching, soreness and burning of tattoos, piercing and waxing.

  • Use

    Tattoo Numbing Cream for tattoos, piercing and waxing, provides deep numbness for up to 7 hours of relief itching, soreness and burning of them.

  • Warnings

    For external use only.
    Keep out of reach of children.
    If swallowed, get medical help.
    Do not use if allergic to any ingredients.
    If pregnant or breastfeeding ask a health professional before use.

  • Do not use

    Allergic reaction occurs to ingredients in this product.

  • When Using

    Do not get into the eyes.
    Do not exceed recommended dosage unless directed by a doctor.
    Do not put this product into the rectum by using fingers or any mechanical device or applicator.

  • Stop Use

    Condition worsens or does not improve within 7 days.
    Allergic reaction occurs to ingredients in this product.
    Symptom being treated does not subside or if redness, irritation.

  • Ask Doctor

    Swelling, pain or other symptoms develop or increase.
    Symptoms clear up and return within a few days.

  • Keep Oot Of Reach Of Children

    If swallowed, get medical help or contact a poison control center right away.

  • Directions

    1.Cleanse targeted skin area, pat dry.
    2.Apply a thick layer (1mm) onto targeted skin area.
    3.Wrap the treated area tightly with plastic wrap and remain for 60 minutes for peak numbing. Conduct a patch test to assess your best numbing timing.
    4.Remove the plastic wrap and wipe away residue, then begin treatment.

  • Other information

    Store in a cool, dry place away from direct sunlight.

  • Inactive ingredients

    Aqua, Glycerin, Isopropyl Palmitate, Aloe Barbadensis Leaf Extract,
    Helianthus Annuus (Sunflower) Seed Oil, Glyceryl Stearate,
    Pentylene Glycol, Cetyl Alcohol, Piper Methysticum Leaf/Root/Stem Extract, Peg-100 Stearate, Tocopheryl Acetate, Panthenol, Camellia Japonica Flower Extract,
    Zingiber Officinale (Ginger) Root Extract, Commiphora Myrrha Extract, Camphor, Menthol, Lecithin, Phenoxyethanol.

  • PRINCIPAL DISPLAY PANEL

    01

  • INGREDIENTS AND APPEARANCE
    SUNHEAL TATTOO NUMBING CREAM 
    sunheal tattoo numbing cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83871-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GINGER (UNII: C5529G5JPQ)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    MACROPIPER METHYSTICUM ROOT (UNII: BOW48C81XP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    MENTHOL (UNII: L7T10EIP3A)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    POLYOXYL 100 STEARATE (UNII: YD01N1999R)  
    COMMIPHORA MYRRHA WHOLE (UNII: UU81N77RI7)  
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    CAMELLIA JAPONICA FLOWER (UNII: KUB8101TNF)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83871-001-0145 g in 1 BOTTLE; Type 0: Not a Combination Product12/18/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01712/18/2023
    Labeler - IBP CORP CO. LTD. (692424700)
    Establishment
    NameAddressID/FEIBusiness Operations
    IBP CORP CO. LTD.692424700label(83871-001) , manufacture(83871-001)