KENDRA SKIN PROTECTION AND PAIN RELIEF FOR HAIR REMOVAL (LANOLIN, PETROLATUM AND LIDOCAINE) KIT [NATUREPLEX, LLC]

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  • KENDRA SKIN PROTECTION AND PAIN RELIEF FOR HAIR REMOVAL (LANOLIN, PETROLATUM AND LIDOCAINE) KIT [NATUREPLEX, LLC]

KENDRA SKIN PROTECTION AND PAIN RELIEF FOR HAIR REMOVAL (LANOLIN, PETROLATUM AND LIDOCAINE) KIT [NATUREPLEX, LLC]
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NDC 67234-048-01
Set ID e422a3ad-9208-41ab-9dc7-9af81f059eae
Category HUMAN OTC DRUG LABEL
Packager Natureplex, LLC
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART347
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  • 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)
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