Label: CERAVINE LIP BALM- oatmeal stick

  • 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 4, 2015

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  • Active ingredient

    Colloidal Oatmeal (0.1%)


  • Purpose

    Skin Protectant


  • Uses

    • Temporarily relieves pain and itching commonly associated with dryness
    • Helps prevent and heal dry; chapped and cracked lips
  • Warnings

    • If irritation or rash persists, consult a physician

    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 between 0 C to 28 C (62 F to 82.4 F)


  • Inactive ingredients

    Ricinus Communis (Castor) Seed Oil, Cera Alba (Beeswax), Olea Europaea (Olive) Fruit Oil, Helianthus Annus (Sunflower) Seed Oil, Persea Gratissima (Avocado) Oil, Hydrogenated Vegetable Oil, Tocopherol, Citrus Sinensis (Orange) Oil, Mentha Piperita (Peppermint) Oil, Propolis Extract, Fibroin


  • Principal Display Panel

    Ceravine LIP BALM

    100% Natural Ingredients

    Net Wt. 0.17 oz (5g)



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  • INGREDIENTS AND APPEARANCE
    CERAVINE LIP BALM 
    oatmeal stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61403-030
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL0.0003 g  in 5 g
    Inactive Ingredients
    Ingredient NameStrength
    CASTOR OIL (UNII: D5340Y2I9G)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61403-030-011 in 1 CARTON
    15 g in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34708/04/2015
    Labeler - Biostandard Inc. (688735402)
    Registrant - Biostandard Inc. (688735402)
    Establishment
    NameAddressID/FEIBusiness Operations
    Biostandard Inc.688735402manufacture(61403-030)
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