Label: DERMOVIX- allantoin,petrolatum patch

  • 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 May 12, 2015

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

  • Drug Facts

  • Active ingredient

    Allantoin 2.00%

    Petrolatum 30.00%

  • Purpose

    Skin Protectant

    Skin Protectant

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If pregnant or breast feeding, contact physician prior to use.

  • Uses

    • Scar Management • Temporarily protects minor cuts, scrapes and burns

  • Warnings

    For external use only

    Do not use

    • on deep or puncture wounds, animal bites, serious burns

    • in large quantities, particularly over raw surfaces or blistered areas

    When using this product

    • avoid contact with eyes

    Stop use and ask a doctor if

    • condition worsens symptoms last more than 7 days or clear up and occur again within a few days

  • DOSAGE & ADMINISTRATION

    Directions adults and children 12 years and over apply to affected area; change patch 1 to 2 times daily

    How to apply

    • clean and dry affected area

    • cut open pouch and remove patch

    • remove protective film and apply directly to area

    • apply to affected area not more than 3 times daily

    • wash hands with soap after applying patch

    • reseal pouch containing unused patches

  • INACTIVE INGREDIENT

    Other ingredients lidocaine, vitamin E, onion extract

  • QUESTIONS

    Questions or comments? call weekdays from 9 AM to 5 PM PST (888) 501-5651

  • STORAGE AND HANDLING

    Other information store below 25°C (77° F), avoid direct sunlight

  • Packaging

    Dermovixlbel

  • INGREDIENTS AND APPEARANCE
    DERMOVIX 
    allantoin,petrolatum patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69440-009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN2 g  in 100 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM30 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    LIDOCAINE (UNII: 98PI200987)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    ONION (UNII: 492225Q21H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69440-009-1515 in 1 BOX
    1100 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/01/2015
    Labeler - Binger Consulting Corporation (079635976)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pocono Coated Products, LLC362785771manufacture(69440-009)