PAN AROMAS BABY (MINERAL OIL) OIL [PAN AROMAS LLC]

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PAN AROMAS BABY (MINERAL OIL) OIL [PAN AROMAS LLC]
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NDC 50346-005-16, 50346-005-17, 50346-005-18, 50346-005-19, 50346-005-20, 50346-005-21, 50346-005-22, 50346-005-23
Set ID cca5a149-01ed-41f8-9cb7-258b94ac94ab
Category HUMAN OTC DRUG LABEL
Packager Pan Aromas LLC
Generic Name
Product Class
Product Number
Application Number PART347
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  • ACTIVE INGREDIENT

    Active Ingredient

    Mineral Oil 99.9%

  • PURPOSE

    Purpose

    Skin Protectant

  • INDICATIONS & USAGE

    Uses

    • Helps moisturize delicate skin and helps prevent chafing.
    • Use after shower or bath for superior moisturizing, helping skin stay soft and smooth.
    • Also used as make-up remover from delicate skin.
  • WARNINGS

    Warnings

    For External Use Only.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children

    Children if swallowed get medical help or contact Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    Apply product liberally, as often as necessary.

  • INACTIVE INGREDIENT

    Inactive Ingredient

    Fragrance

  • SPL UNCLASSIFIED SECTION

    PRINCIPAL DISPLAY PANEL

    Pan Aromas Baby Oil

    NET WT. 10 FL OZ (296 mL)

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    PAN AROMAS BABY 
    mineral oil oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50346-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL99.9 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50346-005-16100 mL in 1 BOTTLE
    2NDC:50346-005-17192 mL in 1 BOTTLE
    3NDC:50346-005-18200 mL in 1 BOTTLE
    4NDC:50346-005-19296 mL in 1 BOTTLE
    5NDC:50346-005-20355 mL in 1 BOTTLE
    6NDC:50346-005-21414 mL in 1 BOTTLE
    7NDC:50346-005-22474 mL in 1 BOTTLE
    8NDC:50346-005-23590 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34712/20/2012
    Labeler - Pan Aromas LLC (078451131)
    Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(50346-005)
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