Drug Facts

Active Ingredients

Menthol 4.50%

Purposes

External Analgesic

Uses:

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

Warnings:

For External Use Only. Avoid Contact With Eyes.

DO NOT Apply

to Open Wounds or Damaged Skin. If symptoms persist for more than seven days, discontinue use and consult physician.

KEEP OUT OF REACH OF CHILDREN.

If swallowed, consult physician. Do not bandage tightly.

If pregnant or breast feeding,

contact physician prior to use.

Directions:

Apply directly to affected area. Do not use more than four times per day.

Other Ingredients:

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Cetyl Alcohol, Diazolidinyl Urea, Isopropyl Myristate, Methyl Paraben, Methyl Salicylate, PEG-8, Propyl Paraber, Propylene Glycol, Sodium Laruyl Sulfate, Triethanolamine.

Package Labeling:

Label

URIFLEX FAST ACTING ANALGESIC PAIN RELIEF
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73168-004
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	45 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
METHYLPARABEN (UNII: A2I8C7HI9T)
METHYL SALICYLATE (UNII: LAV5U5022Y)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TROLAMINE (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:73168-004-00	118 mL in 1 JAR; Type 0: Not a Combination Product	05/20/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	05/20/2019

Labeler - Rejuvica LLC (062848492)

URIFLEX Fast Acting Analgesic Pain Relief Cream