Label: CERAVINE ORIGINAL MOISTURIZING MULTI-PURPOSE- oatmeal jelly

  • 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 July 24, 2015

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  • Active ingredient

    Colloidal Oatmeal (0.1%)


  • Purpose

    Skin Protectant


  • Uses

    • Temporarily relieves pain and itching commonly associated with skin dryness
    • Helps prevent and temporarily protects chafed, chapped or cracked skin
  • Warnings

    • For external use only

    Do not use on

    cuts, scrapes, or broken skins


    Stop use and ask a doctor

    if irritation or rash persists.


    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.


  • Directions

    Apply generously as needed.


  • Other information

    Store below 86 F (30 C)


  • Inactive ingredients

    Ricinus Communis (Castor) Seed Oil, Helianthus Annus (Sunflower) Seed Oil, Olea Europaea (Olive) Fruit Oil, Cera Alba (Beeswax), Hydrogenated Vegetable Oil, Tocopherol, Lavandula Angustifolia (Lavender) Oil, Colloidal Oatmeal


  • Principal Display Panel

    Ceravine ORIGINAL

    ALL NATURAL INGREDIENTS

    Net Wt. 1.7 Fl.oz (50 ml)

    MOISTURIZING MULTI-PURPOSE OIL JELLY




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  • INGREDIENTS AND APPEARANCE
    CERAVINE ORIGINAL  MOISTURIZING MULTI-PURPOSE
    oatmeal jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61403-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL0.0485 g  in 50 g
    Inactive Ingredients
    Ingredient NameStrength
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61403-020-0150 g in 1 CARTON; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/24/2015
    Labeler - Biostandard Inc. (688735402)
    Registrant - Biostandard Inc. (688735402)
    Establishment
    NameAddressID/FEIBusiness Operations
    Biostandard Inc.688735402manufacture(61403-020)
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