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Zeruvia Patch

Generic Name: lidocaine hydrochloride and menthol
Dosage Form: patch

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.

Zeruvia

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%

Purified water, glycerin, polysorbate 80, sodium polyacrylate, Alcohal, carbomer 1342, Pyrrolidone, tartaric acid, titanium dioxide, castor oil, CMC , aluminium glycinate, disodium edetate.

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

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

Topical anesthetic

External analgesic

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ZERUVIA 
lidocaine hydrochloride and menthol patch
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:69054-500
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
WATER  
GLYCERIN  
POLYSORBATE 80  
SODIUM POLYACRYLATE (2500000 MW)  
ALCOHOL  
CARBOMER 1342  
PYRROLIDONE  
TARTARIC ACID  
TITANIUM DIOXIDE  
CASTOR OIL  
CARBOXYMETHYLCELLULOSE  
dihydroxyaluminum aminoacetate  
EDETATE DISODIUM  
Packaging
# Item Code Package Description
1 NDC:69054-500-10 100 g in 1 PACKAGE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 11/14/2014
Labeler - Adler-Stern Pharmaceuticals,LLC (079403232)
Revised: 11/2014
 
Adler-Stern Pharmaceuticals,LLC



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