Label: PREMIUM SCAR PATCH- allantoin, lidocaine, petrolatum patch

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated April 13, 2015

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  • DESCRIPTION

    Active Ingredient

    Allantoin 2.00 %

    Lidocaine 4.00 %

    Pterolatum 30.00 %

  • DESCRIPTION

    Purpose

    Allantoin 2.00 %  ........ Skin Protectant

    Lidocaine 4.00 % ........ Topical Anesthetic

    Petrolatum 30.00 %..... Skin Protectant

  • INDICATIONS & USAGE

    Uses

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

    -Temporary relief of pain associated with minor cuts, scrapes and minor skin irritations

  • WARNINGS

    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

  • DESCRIPTION

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

  • DOSAGE & ADMINISTRATION

    Directions:

    How to apply - clean and dry affected area  -remove mesh from backing and apply to affected area

    -use only one mesh at a time, and maximum of four mesh/day  -leave mesh on affected area for up to

    8 hours  -do not use mesh for longer than 5 consecutive days  -children under 12 should consult

    physician prior to use

  • STORAGE AND HANDLING

    Other Information: store below 25C (77F), avoid direct sunlight

  • DESCRIPTION

    Questions or comments? call weekdays from 9 AM to 5 PM CST 800-914-7435

  • PRINCIPAL DISPLAY PANEL

    copy of label

  • INGREDIENTS AND APPEARANCE
    PREMIUM SCAR PATCH 
    allantoin, lidocaine, petrolatum patch
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:69512-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN2 g  in 100 g
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE5 g  in 100 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM30 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    ONION (UNII: 492225Q21H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69512-020-0115 in 1 BOX
    115 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/15/2015
    Labeler - Alivio Medical Products, LLC (079670828)
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