Label: PURTECT- petrolatum, chloroxylenol ointment

  • 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 May 15, 2012

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  • Active Ingredients

    Drug Facts

    Active ingredients

    Petrolatum 63%    Chloroxylenol 0.8%

  • Purpose

    Purpose

    Skin Protectant  Antiseptic

  • 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.

  • Uses

    Uses

    Temporarily protects:

    • minor cuts, scrapes and burns
    • temporarily protects and helps relieve chafed or cracked skin
    • help protects from the drying effects of wind and cold weather
  • Warnings

    Warnings

    • For external use only
    • do not get near eyes
    Do not use on
    • deep puncture wounds
    • animal bites
    • serious burns
    Do not use if you are allergic to any ingredients listed
    Stop use and ask a doctor if
    • condition worsens
    • irritation, rash or other allergic reaction develops
  • Directions

    Directions

    • Thoroughly clean affected area and allow to dry
    • Apply ointment sparingly on affected area as needed
  • Other Information

    Other information

    • Reseal container after use
    • Avoid freezing
    • Store between 4 degrees and 30 degrees C (40 degrees and 86 degrees F)
    • See tube crimp for lot number and expiration date
  • Inactive Ingredients

    Inactive Ingredients: Paraffium Liquidum, Paraffin, Propylene Glycol, Tocopheryl Acetate, Squalane, Retinyl Palmitate, Cocos Nucifera (Coconut) Oil, Aloe Barbadensis Leaf Extract

  • Package Label

    PurTect

    Topical Ointment and Skin Protectant

    Helps protect the Skin's Moisture Barrier

    Enriched with Vitamins A and E

    Helps Prevent Damage Caused by Dryness

    4 Fl. Oz (118 mL)

    NDC 49436-xxx-xx

    Made in Canada    Distributed in the U.S.A. by PurKlenz Formulations Inc.

    Questions or comments? www.purklenz.com


    PurKlenz PurTect5 Label




    PurKlenz PurTect4 Label




  • INGREDIENTS AND APPEARANCE
    PURTECT 
    petrolatum, chloroxylenol ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49436-290
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM63 mL  in 100 mL
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.8 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SQUALANE (UNII: GW89575KF9)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49436-290-01118 mL in 1 TUBE
    2NDC:49436-290-0220 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34605/01/2012
    Labeler - PurKlenz Formulations Inc. (078444179)
    Registrant - PurKlenz Formulations Inc. (078444179)
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