Label: MEDROX- menthol, capsaicin, methyl salicylate patch
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Contains inactivated NDC Code(s)
NDC Code(s): 45861-009-05 - Packager: Pharmaceutica North America, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated December 1, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
- Inactive ingredients
- Keep out of reach of children
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Administration
adults and children 12 years and over apply to affected area; change patch 1 to 2 times daily.
children under 12 years, consult physician before use.
How to apply:
clean and dry affected area
cut open pouch and remove patch
remove protective film and apply directly to area of pain
apply to affected are not move than 3 times daily
wash hands with soap after applying patch
reseal pouch containing unused patches
- Use
- Purpose
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Warnings
for external use only. use only as directed. avoid contact with eyes and mucous membranes.
do not cover with bandage.
do not use on wounds or damaged skin.
keep out of reach of children. consult physician for children under 12.
do not use if you are allergic to methyl salicylate or menthol.
stop use and ask a doctor if conditions worsen, symptoms persist for more than 7 days or clear up and occur again within a few days.
if rash, itching or excessive skin irritations occurs.
- Storage
- Package display
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INGREDIENTS AND APPEARANCE
MEDROX
menthol, capsaicin, methyl salicylate patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:45861-009 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 5 g in 100 g CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 0.0375 g in 100 g METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 5 g in 100 g Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) ALOE VERA LEAF (UNII: ZY81Z83H0X) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) DISODIUM SULFOSALICYLATE (UNII: WFP6MAA96R) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) METHYLPARABEN (UNII: A2I8C7HI9T) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLPARABEN (UNII: Z8IX2SC1OH) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:45861-009-05 5 g in 1 PATCH Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 10/27/2011 Labeler - Pharmaceutica North America, Inc. (962739699) Registrant - Pharmaceutica North America, Inc. (962739699)
