SUPRADERM (WHITE PETROLATUM, LANOLIN) CREAM [OLEN COSMETICS CORPORATION]

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SUPRADERM (WHITE PETROLATUM, LANOLIN) CREAM [OLEN COSMETICS CORPORATION]
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NDC 52358-0002-1, 52358-0002-2, 52358-0002-3
Set ID 4e7199bd-52c6-48e9-9c78-c84e45412faf
Category HUMAN OTC DRUG LABEL
Packager Olen Cosmetics Corporation
Generic Name
Product Class
Product Number
Application Number PART347
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients

    30% White Petrolatum

    15% Lanolin

  • PURPOSE

    Purpose

    Skin Protectant

  • INDICATIONS & USAGE

    Uses

    Temporarily Protects Minor:

    • Cuts
    • Scrapes
    • Burns
    • Temporarily protects and helps relieve chapped or cracked skin
    • Helps protect from the drying effects of wind and cold weather
  • WARNINGS

    Warnings

    For External Use Only

  • WHEN USING

    When using this product

    • Do not get into eyes
  • ASK DOCTOR

    Stop use and ask a doctor if

    • Condition worsens
    • Symptoms last more that 7 days or clear up and occur again within a few days
  • DO NOT USE

    Do not use on

    • Deep or puncture wounds
    • Animal bites
    • Serious burns
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children. If swallowed, get medical help or contact a Poison control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    Apply liberally to affected area of the skin as needed.

  • STORAGE AND HANDLING

    Other information

    Store between 59-86°F

  • INACTIVE INGREDIENT

    Inactive ingredients

    zinc oxide, corn starch

  • QUESTIONS

    Questions? 1-877-494-4313

  • PRINCIPAL DISPLAY PANEL

    SUPRADERM

    Skin Protectant

    Barrier & Healing Cream

    100% NATURAL

    HYPOALLERGENIC

    NDC 52358-0002-3

    NET WT 16 OZ.

    Supraderm 16 oz

  • INGREDIENTS AND APPEARANCE
    SUPRADERM 
    white petrolatum, lanolin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52358-0002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM0.3 g  in 1 g
    LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN0.15 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52358-0002-1113 g in 1 JAR; Type 0: Not a Combination Product11/02/2015
    2NDC:52358-0002-2340 g in 1 JAR; Type 0: Not a Combination Product11/02/2015
    3NDC:52358-0002-3454 g in 1 JAR; Type 0: Not a Combination Product11/02/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34710/17/2014
    Labeler - Olen Cosmetics Corporation (250916611)
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