Label: KENDRA SKIN PROTECTION AND PAIN RELIEF FOR HAIR REMOVAL- lanolin, petrolatum and lidocaine kit

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 October 20, 2017

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

  • SPL UNCLASSIFIED SECTION

    A&D OINTMENT

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Lanolin 15.5%Skin Protectant
    Petrolatum 53.4%Skin protectant
  • Use

    • temporarily protects and helps relieve minor skin irritation due to tattooing, piercing, and hair removal
  • Warnings

    For external use only

    When using this product

    • do not get into eyes

    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

    Do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns

    Keep out of reach of children. If swallowed, get medical help, or contact a Poison Control Center immediately: 1-800-222-1222.

  • Directions

    • After procedure, apply A&D Skin Protectant as needed to affected skin.
  • Other information

    • see bottom of carton for lot number and expiration date
    • store at 15 to 30°C (59 to 86°F)
    • do not use if carton is damaged or open
    • do not use if seal on tube is punctured or missing
  • Inactive ingredients

    beeswax, cod liver oil (contains vitamin A & vitamin D), fragrance, light mineral oil, microcrystalline wax

  • Questions or Comments?

    1-866-323-0107 or www.kendracollection.com

  • SPL UNCLASSIFIED SECTION

    4% LIDOCAINE

    Drug Facts

  • Active ingredient

    Lidocaine 4%

  • Purpose

    Pain Relieving Cream

  • Use

    • for temporary relief of pain associated with minor skin irritations due to tattooing, piercing, and hair removal
  • Warnings

    For external use only

    Avoid contact with the eyes

    Do Not Use

    • if you are allergic to any ingredient in lidocaine cream or to similar medicines (e.g., local anesthetics such as benzocaine)
    • in large quantities, particularly over raw surfaces or blistered areas

    Ask a doctor before use

    • if you have had an allergic reaction (e.g., rash, hives, dizziness) to any anesthetic medicine

    Stop use and ask a doctor if

    • you develop a persistent rash
    • conditions worsens or if symptoms persist for more than 7 days or 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 immediately: 1-800-222-1222.

  • Directions

    • For adult use only.
    • Before procedure, apply a small amount of pain relieving cream to affected area, and allow to dry. Application may be repeated up to 4 times daily.
  • Other information

    • see bottom of carton for lot number and expiration date
    • store at 15 to 30°C (59 to 86°F)
    • do not use if carton is damaged or open
    • do not use if seal on tube is punctured or missing
  • Inactive ingredients

    aloe barbadensis leaf juice, benzophenone-4, cetyl alcohol, dimethyl sulfoxide, jeecide cap-5, L-arginine, purified water, simmondsia chinesis (jojoba) seed oil, sodium polyacrylate, stearic acid, tea tree oil

  • Questions or Comments?

    1-866-323-0107 or www.kendracollection.com

  • SPL UNCLASSIFIED SECTION

    This product
    is manufactured
    and distributed
    by Natureplex™.

  • PRINCIPAL DISPLAY PANEL - Kit Carton

    NDC# 67234-048-01

    KENDRA

    PAIN RELIEF & SKIN PROTECTANT

    A&D OINTMENT SKIN PROTECTANT
    1 TUBE NET WT. 1.75 Oz. (49.6g)

    LIDOCAINE 4% PAIN RELIEVING CREAM
    1 TUBE NET WT. 1.75 Oz. (49.6g)

    PRINCIPAL DISPLAY PANEL - Kit Carton
  • INGREDIENTS AND APPEARANCE
    KENDRA SKIN PROTECTION AND PAIN RELIEF FOR HAIR REMOVAL 
    lanolin, petrolatum and lidocaine kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67234-048
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67234-048-011 in 1 CARTON06/04/2003
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 28 g
    Part 21 TUBE 28 g
    Part 1 of 2
    A AND D 
    lanolin and petrolatum ointment, augmented
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Lanolin (UNII: 7EV65EAW6H) (Lanolin - UNII:7EV65EAW6H) Lanolin155 mg  in 1 g
    Petrolatum (UNII: 4T6H12BN9U) (Petrolatum - UNII:4T6H12BN9U) Petrolatum534 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    COD LIVER OIL (UNII: BBL281NWFG)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    128 g in 1 TUBE; Type 8: Possible Combination Based on Cross Labeling of Separate Products (Temporary Type)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/04/2003
    Part 2 of 2
    LIDOCAINE PAIN RELIEVING 
    lidocaine cream
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Lidocaine (UNII: 98PI200987) (Lidocaine - UNII:98PI200987) Lidocaine40 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHYL SULFOXIDE (UNII: YOW8V9698H)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ARGININE (UNII: 94ZLA3W45F)  
    WATER (UNII: 059QF0KO0R)  
    JOJOBA OIL (UNII: 724GKU717M)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    128 g in 1 TUBE; Type 8: Possible Combination Based on Cross Labeling of Separate Products (Temporary Type)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/25/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/04/2003
    Labeler - Natureplex, LLC (062808196)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natureplex LLC062808196MANUFACTURE(67234-048)