REME D- menthol, capsaicin patch

REME D by

Drug Labeling and Warnings

REME D by is a Otc medication manufactured, distributed, or labeled by Geritrex Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Keep out of reach of children. Consult physician for children under 12.

STORAGE AND HANDLING

Storage Condition 15°-30°C (59°-86°F)

DOSAGE & ADMINISTRATION

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

REME D 
menthol, capsaicin patch

Product 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)