REME D- menthol, capsaicin patch 
Geritrex Corp

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.

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REME + D Patch

Drug Facts

Active Ingredients                              Purpose

Menthol 5%                                     Topical Analgesic

Capsaicin 0.025%                            Topical Analgesic

Uses

For temporary relief of minor aches & pains of muscles & joints associated with arthritis, simple backache, strains, bruises, and sprains.

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. Consult physician for children under 12.

Storage Condition 15°-30°C (59°-86°F)

Discontinue use at least 1 hour befor a bath or shower and do not use immediately after a bath or shower.

Label of Patch

REME D 
menthol, capsaicin patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-560
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5.0 g  in 100 g
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.025 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54162-560-157 g in 1 PATCH02/20/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/20/2015
Labeler - Geritrex Corp (112796248)
Registrant - Geritrex Corp (112796248)
Establishment
NameAddressID/FEIBusiness Operations
Geritrex Corp112796248manufacture(54162-560)

Revised: 2/2015
Document Id: efeb5c71-df19-48b3-8c85-eb5d22e99df7
Set id: 659c9fb1-afd4-440c-be96-32cf2c8ebf15
Version: 1
Effective Time: 20150220
 
Geritrex Corp