SYNVEXIA- lidocaine hydrochloride and menthol patch 
Sterling Knight Pharmaceuticals,LLC

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.

----------

Synvexia

Warnings

For external use only

Avoid contact with eyes

Do not applly to open wounds or damaged skin

If symptoms persist for more than seven days, discontinue use and consult physician

If swallowed, consult physician

Do not bandage tightly

If pregnant or breast feeding, contact physician prior to use

Do not use in large quantities, particularly over raw surfaces or blistered areas

Keep out of reach of children

Lidocaine HCL 4.00%

Menthol 1.00%

Silicon Dioxide.

clean and dry affected area

remove patch from backing and apply to affected area

use only one patch at a time, and maximum of four patches/day

leave patch on affected area for up to 8 hours

do not use patches for longer than five consecutive days

children under 12 should consult physician prior to use

How Supplied

Use only one patch at a time, and maximum of four patches/day. leave patch on affected area for up to 8 hours

NDC:69336-200-05      5 in 1 BOX

NDC:69336-200-10    10 in 1 BOX

NDC:69336-200-15    15 in 1 BOX

NDC:69336-200-30    30 in 1 BOX

NDC:69336-200-60    60 in 1 BOX

INDICATIONS AND USAGE

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

Topical anesthetic

External analgesic

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

synvexianew

SYNVEXIA 
lidocaine hydrochloride and menthol patch
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:69336-200
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69336-200-10100 g in 1 PACKAGE; Type 0: Not a Combination Product11/14/201407/30/2018
2NDC:69336-200-055 in 1 BOX11/14/201407/30/2018
2100 g in 1 PACKAGE; Type 0: Not a Combination Product
3NDC:69336-200-1515 in 1 BOX11/14/201407/30/2018
3100 g in 1 PACKAGE; Type 0: Not a Combination Product
4NDC:69336-200-3030 in 1 BOX11/14/201407/30/2018
4100 g in 1 PACKAGE; Type 0: Not a Combination Product
5NDC:69336-200-6060 in 1 BOX11/14/201407/30/2018
5100 g in 1 PACKAGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other11/14/201407/30/2018
Labeler - Sterling Knight Pharmaceuticals,LLC (079556942)
Registrant - Sterling Knight Pharmaceuticals,LLC (079556942)

Revised: 7/2018
Document Id: 6cb1fb6d-c4bc-4dcc-a317-20ca3b652869
Set id: 8c707cfd-6f5e-4949-8cdf-504049464a1e
Version: 11
Effective Time: 20180731
 
Sterling Knight Pharmaceuticals,LLC