MEDIRELIEF ULTRA- menthol patch

MediRelief by

Drug Labeling and Warnings

MediRelief by is a Otc medication manufactured, distributed, or labeled by FARLA MEDICAL HEALTHCARE LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients & Purpose

Active ingredients (in each patch) Purpose

Menthol 5%..............................................................................................Topical analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with

 simple backache  arthritis  strains  sprains

Warnings

FOR EXTERNAL USE ONLY. Avoid contact with the eyes.

Do not use

 on wounds or damaged skin  on a tight bandage  with a heating pad

 on sensitive skin  if allergic to any ingredients in this product

Stop use and ask a doctor if

 condition worsens  redness is present

 symptoms persist for more than 7 days or clear up and occur again within a few days

If pregnant of breast-feeding

ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

 adults & children 12 years of age and older: apply to affected area not more than 3 to 4 times daily

 children under 12 years of age: consult a doctor

Other Information

 store at room temperature 68-77°F (20-25°C)  do not store in direct sunlight or expose to excessive heat and moisture

TAMPER EVIDENT: Do not use if pouch containing the patch is torn or broken.

Inactive Ingredients

dihydroxyaluminum aminoacetate, glycerin, kaolin,

methylparaben, polyacrylic acid, polysorbate 80, povidones, propylene glycol, propylparaben, sodium polyacrylate, tartaric acid, titanium dioxide, water

Principal Display Panel

(Medium) Patch
NDC: 73486-101-25

(Large) Patch
NDC: 73486-101-35

INGREDIENTS AND APPEARANCE

MEDIRELIEF  ULTRA
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73486-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	5 g

Inactive Ingredients
Ingredient Name	Strength
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)
POVIDONE (UNII: FZ989GH94E)
METHYLPARABEN (UNII: A2I8C7HI9T)
KAOLIN (UNII: 24H4NWX5CO)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TARTARIC ACID (UNII: W4888I119H)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73486-101-25	5 in 1 CARTON	05/04/2020
1		1 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 73486-101-35	5 in 1 CARTON	05/04/2020
2		1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/04/2020

Labeler - FARLA MEDICAL INT LTD (221985675)