Synvexia

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.

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

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(click image for full-size original)

SYNVEXIA
lidocaine hydrochloride and menthol patch
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69336-200
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS 4 g in 100 g
MENTHOL (MENTHOL) MENTHOL 1 g in 100 g
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69336-200-10 100 g in 1 PACKAGE None
2 NDC:69336-200-05 5 PACKAGE in 1 BOX contains a PACKAGE
2 100 g in 1 PACKAGE This package is contained within the BOX (69336-200-05)
3 NDC:69336-200-15 15 PACKAGE in 1 BOX contains a PACKAGE
3 100 g in 1 PACKAGE This package is contained within the BOX (69336-200-15)
4 NDC:69336-200-30 30 PACKAGE in 1 BOX contains a PACKAGE
4 100 g in 1 PACKAGE This package is contained within the BOX (69336-200-30)
5 NDC:69336-200-60 60 PACKAGE in 1 BOX contains a PACKAGE
5 100 g in 1 PACKAGE This package is contained within the BOX (69336-200-60)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 11/14/2014
Labeler — Sterling Knight Pharmaceuticals,LLC (079556942)

Revised: 03/2015 Sterling Knight Pharmaceuticals,LLC

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