Label: SCADEXE- allantoin, lidocaine, petrolatum patch

  • Category: HUMAN OTC DRUG LABEL

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 April 15, 2015

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  • Active Ingredient Section

    Active Ingredient

    Allantoin 2.00 %

    Lidocaine 4.00 %

    Petrolatum 30.00 %

  • ASK DOCTOR SECTION

    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

  • DO NOT USE SECTION

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

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

  • KEEP OUT OF REACH OF CHILDREN

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

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding, contact physician prior to use

  • PURPOSE

    - Temporarily protects minor cuts , scrapes and burns

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

  • QUESTIONS

    For questions or comments please call 800-317-2910

  • STOP USE SECTION

    Stop use if condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days.

  • WHEN USING SECTION

    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

  • Package Label

    scadexe_large_low_res

  • Dosage and Administration These highlights do not include all the information needed to use

  • Warnings

    Stop use if condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days.

    Do not use if pregnant.

    Keep away from Children

  • Inactive Ingredients These highlights do not include all the information needed to use

    ONION

    ALPHA-TOCOPHEROL

  • Indications and usage

  • INGREDIENTS AND APPEARANCE
    SCADEXE 
    allantoin, lidocaine, petrolatum patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69329-040
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE4 g  in 100 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM30 g  in 100 g
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ONION (UNII: 492225Q21H)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69329-040-3030 in 1 BOX
    110 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/15/2015
    Labeler - Patchwerx Labs, Inc. (079584480)
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