Label: PAN AROMAS BABY- mineral oil oil 

  • NDC Code(s): 50346-005-16, 50346-005-17, 50346-005-18, 50346-005-19, view more
    50346-005-20, 50346-005-21, 50346-005-22, 50346-005-23
  • Packager: Pan Aromas LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 12/12

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredient

    Mineral Oil 99.9%

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  • PURPOSE

    Purpose

    Skin Protectant

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  • 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.
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  • WARNINGS

    Warnings

    For External Use Only.

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  • 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.

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  • DOSAGE & ADMINISTRATION

    Directions

    Apply product liberally, as often as necessary.

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  • INACTIVE INGREDIENT

    Inactive Ingredient

    Fragrance

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  • SPL UNCLASSIFIED SECTION

    PRINCIPAL DISPLAY PANEL

    Pan Aromas Baby Oil

    NET WT. 10 FL OZ (296 mL)

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  • INGREDIENTS AND APPEARANCE
    PAN AROMAS BABY 
    mineral oil oil
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:50346-005
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MINERAL OIL (MINERAL OIL) MINERAL OIL 99.9 mL  in 100 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50346-005-16 100 mL in 1 BOTTLE
    2 NDC:50346-005-17 192 mL in 1 BOTTLE
    3 NDC:50346-005-18 200 mL in 1 BOTTLE
    4 NDC:50346-005-19 296 mL in 1 BOTTLE
    5 NDC:50346-005-20 355 mL in 1 BOTTLE
    6 NDC:50346-005-21 414 mL in 1 BOTTLE
    7 NDC:50346-005-22 474 mL in 1 BOTTLE
    8 NDC:50346-005-23 590 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 12/20/2012
    Labeler - Pan Aromas LLC (078451131)
    Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)
    Establishment
    Name Address ID/FEI Business Operations
    Jell Pharmaceuticals Pvt. Ltd. 726025211 manufacture(50346-005)
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