SCADEXE- allantoin, lidocaine, petrolatum patch

SCADEXE by

Drug Labeling and Warnings

SCADEXE by is a Otc medication manufactured, distributed, or labeled by Patchwerx Labs, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69329-040
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE	4 g  in 100 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	30 g  in 100 g
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ONION (UNII: 492225Q21H)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69329-040-30	30 in 1 BOX
1		10 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/15/2015

Labeler - Patchwerx Labs, Inc. (079584480)