AnodyneRx

Name: AnodyneRx

Contraindications

AnodyneRx Patch is contraindicated for those patients with a history of hypersensitivity to any of the components of the preparation.

Warnings

  • For external use only.
  • Avoid contact with eyes and mucous membranes.
  • Do not apply to open wounds or damaged skin or use with a heating pad.
  • Does not require additional cover bandage.
  • Do not use if allergic or sensitive to Menthol or Lidocaine.
  • Stop use and ask a doctor if condition worsen, symptoms persist for more than 7 days.
  • Stop use and ask a doctor if condition worsen, symptoms persist for more than 7 days or clear up and occur again within a few days.
  • Contact physician if rash, blistering, itching or excessive skin irritation occurs.
  • If swallowed, consult physician.
  • If pregnant or breast feeding, contact a physician prior to use.
  • KEEP OUT OF REACH OF CHILDREN.

AnodyneRx Patch Label

NDC 75840-090-15                              Rx only

AnodyneRx Patch

MEDICATED PATCH

(5% Menthol, 2.5% Lidocaine 0.05% Capsaicin)

For Topical Use Only

15 PATCHES                  Patch Size: 8cm x 12 cm                 Qty: 15 Patches

Distributed By:
GenPak Solutions LLC
4324 Reynolds Drive
Hilliard, Ohio 43026

Lot #:
Expiration Date:

AnodyneRx  
menthol, unspecified form, lidocaine, capsaicin patch
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:75840-090
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL, UNSPECIFIED FORM (MENTHOL, UNSPECIFIED FORM) MENTHOL, UNSPECIFIED FORM 5 g
LIDOCAINE (LIDOCAINE) LIDOCAINE 2.5 g
CAPSAICIN (CAPSAICIN) CAPSAICIN 0.05 g
Inactive Ingredients
Ingredient Name Strength
ACRYLIC ACID  
ALUMINUM HYDROXIDE  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM  
2-ETHYLHEXYL ACRYLATE  
GLYCERIN  
ISOPROPYL MYRISTATE  
METHYL ACRYLATE  
NONOXYNOL-30  
POLYACRYLIC ACID (250000 MW)  
POLYSORBATE 80  
SORBITAN SESQUIOLEATE  
TALC  
TARTARIC ACID  
TITANIUM DIOXIDE  
WATER  
Packaging
# Item Code Package Description
1 NDC:75840-090-15 15 PATCH (PATCH) in 1 BOX
2 NDC:75840-090-05 5 PATCH (PATCH) in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 04/01/2015
Labeler - GenPak Solutions LLC (041670194)
Registrant - GenPak Solutions LLC (041670194)
Revised: 03/2015   GenPak Solutions LLC

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Very bad irritation where this drug is used.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Irritation where this drug is used.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Some side effects of capsaicin / lidocaine / menthol topical may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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