SCADEXE- allantoin, lidocaine, petrolatum patch 
Patchwerx Labs, Inc.

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.

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SCADEXE PATCH

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

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)

Revised: 4/2015
Document Id: 13cfbd7c-759c-73ca-e054-00144ff8d46c
Set id: 13cfbd7c-759b-73ca-e054-00144ff8d46c
Version: 1
Effective Time: 20150415
 
Patchwerx Labs, Inc.