Label: LIDENZA PATCH- lidocaine hydrochloride patch
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Contains inactivated NDC Code(s)
NDC Code(s): 69329-017-15, 69329-017-25 - Packager: Patchwerx Labs, Inc.
- This is a repackaged label.
- Source NDC Code(s): 49430-017
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Drug Label Information
Updated November 15, 2014
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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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
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
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DOSAGE & ADMINISTRATION
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
- INDICATIONS & USAGE
- PURPOSE
- Lidenza Patch
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INGREDIENTS AND APPEARANCE
LIDENZA PATCH
lidocaine hydrochloride patchProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69329-017(NDC:49430-017) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 4 g in 100 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) ARNICA MONTANA (UNII: O80TY208ZW) POLYSORBATE 80 (UNII: 6OZP39ZG8H) ALOE VERA LEAF (UNII: ZY81Z83H0X) BOSWELLIA SACRA WHOLE (UNII: 8O600AZL0W) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CARBOMER 1342 (UNII: 809Y72KV36) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) PEG-8 GLYCERYL ISOSTEARATE (UNII: 74QQ5X3KL1) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TRIETHANOLAMINE BENZOATE (UNII: M3EN4GC19W) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69329-017-15 100 g in 1 PACKAGE 2 NDC:69329-017-25 100 g in 1 PACKAGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 10/01/2013 Labeler - Patchwerx Labs, Inc. (079584480)
