Label: REME D- menthol, capsaicin patch
-
Contains inactivated NDC Code(s)
NDC Code(s): 54162-560-15 - Packager: Geritrex Corp
- 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 February 20, 2015
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Uses
-
Instructions for use
Clean and dry the affected area.
Open pouch and remove one patch.
Remove any protective film and apply directly to affected area of pain. Apply immedi-ately after removal from the protective envelope.
Wash hands with soap and water after handling the patches.
Reseal pouch containing unused patches after each use. Do not store patch outside the sealed envelope.
Discontinue use at least 1 hour before a bath or shower and do not use immediately after a bath or shower.
Fold used patches so that the adhesive side sticks to itself and safely discard used patches or pieces of cut patches where children and pets cannot get to them
-
Warnings
For external use only.
Use only as directed or by a health professional
Do not use: On wounds, cuts, damaged or infected skin. On eyes, mouth, genitals, or any other mucous membranes.
Stop and consult your physician if pregnant or pain worsens.
Allergy Alert: If you are allergic to any ingredients of this product or chili peppers contact a doctor before use
- Other Ingredients
- KEEP OUT OF REACH OF CHILDREN
- STORAGE AND HANDLING
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
REME D
menthol, capsaicin patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54162-560 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 5.0 g in 100 g CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 0.025 g in 100 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) GLYCERIN (UNII: PDC6A3C0OX) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) LEMON OIL (UNII: I9GRO824LL) METHYLPARABEN (UNII: A2I8C7HI9T) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLPARABEN (UNII: Z8IX2SC1OH) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54162-560-15 7 g in 1 PATCH 02/20/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 02/20/2015 Labeler - Geritrex Corp (112796248) Registrant - Geritrex Corp (112796248) Establishment Name Address ID/FEI Business Operations Geritrex Corp 112796248 manufacture(54162-560)
