Label: THERAPLEX HEALING EMOLLIENT- petrolatum cream

  • 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 23, 2015

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  • Drug Facts

  • Active Ingredient

    Petrolatum (65%)

  • Purpose

    Skin Protectant

  • 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

    • temporarily protects and helps relieve chapped or cracked skin and lips • helps protect from the drying effects of wind and cold weather • temporarily protects minor: • cuts • scrapes • burns

  • WARNINGS

    Warnings  For external use only

    When using this product do not get into eyes.

    Stop and ask a doctor if  • condition worsens • symptoms last 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

  • DOSAGE & ADMINISTRATION

    Directions  apply as needed, or as directed by your doctor.

  • INACTIVE INGREDIENT

    Inactive Ingredients  cyclomethicone, microcrystalline wax

  • STORAGE AND HANDLING

    Other information  • store at room temperature • keep from freezing

  • QUESTIONS

    Questions?   call 1-888-437-2753

  • SPL UNCLASSIFIED SECTION

    Clinically-proven Theraplex Healing Emollient combines a unique enriched special petrolatum fraction (ESPF) with a novel hydrosilicone delivery system that deeply penetrates severely dry skin. Dermatologists have recommended this healing formulation for years because of its ability to deliver soothing moisturization and long-lasting skin barrier protection with no irritation to sensitive, compromised skin.

    • Noncomedogenic (Won't Clog Pores)

    • Hypoallergenic

    • Preservative-Free

    • Fragrance-Free

    • Paraben-Free

    • Gluten-Free

    Skin Protectant • For Severely Dry & Sensitive Skin

    Dermatologist recommended for adults & children

    Net Wt.  8oz. (226.7g)

    Distributed by:

    The Theraplex Company, LLC

    Memphis, TN 38119

    www.theraplex.com

  • Packaging

    ther1

  • INGREDIENTS AND APPEARANCE
    THERAPLEX  HEALING EMOLLIENT
    petrolatum cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62917-065
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM65 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62917-065-08226.7 g in 1 JAR; Type 0: Not a Combination Product10/23/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34710/23/2015
    Labeler - The Theraplex Company, LLC (363529392)
    Establishment
    NameAddressID/FEIBusiness Operations
    Memphis Contract Packaging, Inc.185390010manufacture(62917-065)
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