Label: MINERAL OIL LIGHT, N.F- mineral oil oil

  • 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 August 28, 2017

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  • Active Ingredient:

    Mineral Oil 100%   

  • Use:

    Helps treat and prevent diaper rash, protects chafted skin and seals out wetness.

  • Protects skin.

  • Keep out of reach of children

  • WARNINGS

    ​Caution: For External Use Only

    ​In case of accidental ingestion seek professional assistance or contact a Poison Control Center immediately. Avoid contact with eyes. In case of accidental eye contactl flush eyes gently with water for 15 minutes. Obtain medical attention if irritation persists. If diaper rash worsens or does not improve consult a physician

  • DOSAGE & ADMINISTRATION

    Clean area thoroughly and allow to dry. Apply mineral oil liberally and as often as needed. Protects the skin against wetness.

  • INACTIVE INGREDIENT

    Contains:

    dl-alpha-tocopherol as preservative. Keep tightly closed and protect from direct sunlight.

  • STORAGE AND HANDLING

    Store at room temperature 15-30°C (59-86°F)

  • PRINCIPAL DISPLAY PANEL

    image description

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  • INGREDIENTS AND APPEARANCE
    MINERAL OIL LIGHT, N.F 
    mineral oil oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-185
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL471.99 g  in 472 mL
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01) 0.00472 g  in 472 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54162-185-16472 mL in 1 BOTTLE; Type 0: Not a Combination Product07/31/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/31/2015
    Labeler - GERITREX LLC (112796248)
    Registrant - GERITREX LLC (112796248)
    Establishment
    NameAddressID/FEIBusiness Operations
    GERITREX LLC112796248manufacture(54162-185)
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