SCADEXE (ALLANTOIN, LIDOCAINE, PETROLATUM) PATCH [PATCHWERX LABS, INC.]

SCADEXE (ALLANTOIN, LIDOCAINE, PETROLATUM) PATCH [PATCHWERX LABS, INC.]
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NDC 69329-040-30
Set ID 13cfbd7c-759b-73ca-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Patchwerx Labs, Inc.
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
  • 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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