Label: RENUU PATCH- allantoin, lidocaine, petrolatum patch

  • Category: HUMAN PRESCRIPTION DRUG LABEL

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated May 27, 2015

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  • INACTIVE INGREDIENT

    Other Ingredients vitamin E, onion extract

  • DESCRIPTION

    Active Ingredient

    Allantoin 2.00 %

    Lidocaine 5.00 %

    Petrolatum 30.00 %

  • DESCRIPTION

    Purpose

    Skin Protectant

    Topical Anesthetic

    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

    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 persist for more than 7 days or clear up and occur again within a few days

    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 - children under 12 should consult

    physician prior to use

  • STORAGE AND HANDLING

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

  • SPL UNCLASSIFIED SECTION

    For questions or concerns about this product, please call us - weekdays from 9 AM to 5 PM PST (1) 800-590-8070

  • PRINCIPAL DISPLAY PANEL

    renuu_low_res_box_flat.jpg

  • INGREDIENTS AND APPEARANCE
    RENUU PATCH 
    allantoin, lidocaine, petrolatum patch
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:69329-012
    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:69329-012-1515 in 1 BOX
    1NDC:69329-012-01100 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/15/2014
    Labeler - Patchwerx Labs (079584480)