URIFLEX Fast Acting Analgesic Pain Relief Cream

Manufacturer: Rejuvica LLC
Effective date: 2023-11-05
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 23:59:10

Label at a glance#

ProductURIFLEX Fast Acting Analgesic Pain Relief

Active ingredientMENTHOL

Label structure6 sections

Indications and uses

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

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 4.50%

Purposes

OTC - PURPOSE SECTION

External Analgesic

Uses:

INDICATIONS & USAGE SECTION

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

Warnings:

WARNINGS SECTION

For External Use Only. Avoid Contact With Eyes.

DO NOT Apply

OTC - DO NOT USE SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, consult physician. Do not bandage tightly.

If pregnant or breast feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

contact physician prior to use.

Directions:

DOSAGE & ADMINISTRATION SECTION

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

Other Ingredients:

INACTIVE INGREDIENT SECTION

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:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
2171392	menthol 4.5 % Topical Cream	PSN	2
2171392	menthol 45 MG/ML Topical Cream	SCD	2
2171392	menthol 4.5 % Topical Cream	SY	2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
73168-004-00	URIFLEX Fast Acting Analgesic Pain Relief	118 mL in 1 JAR	CREAM	118		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
73168-004	URIFLEX FAST ACTING ANALGESIC PAIN RELIEF (MENTHOL) CREAM [REJUVICA LLC]	2	Current NDC, Legacy NDC, 1 package rows	20231106_fb78f705-b838-461d-b42c-8c98d3ca5d09.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

URIFLEX Fast Acting Analgesic Pain Relief
MENTHOL
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)
ALOE VERA LEAF
WATER
CETYL ALCOHOL
DIAZOLIDINYL UREA
ISOPROPYL MYRISTATE
METHYLPARABEN
METHYL SALICYLATE
POLYETHYLENE GLYCOL 400
PROPYLPARABEN
PROPYLENE GLYCOL
SODIUM LAURYL SULFATE
TROLAMINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
73168-004	73168-004-00

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)	59TL3WG5CO	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
WATER	059QF0KO0R	IACT
CETYL ALCOHOL	936JST6JCN	IACT
DIAZOLIDINYL UREA	H5RIZ3MPW4	IACT
ISOPROPYL MYRISTATE	0RE8K4LNJS	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
METHYL SALICYLATE	LAV5U5022Y	IACT
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
TROLAMINE	9O3K93S3TK	IACT
MENTHOL	L7T10EIP3A	ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
URIFLEX Fast Acting Analgesic Pain Relief	MENTHOL	Rejuvica LLC	fb78f705-b838-461d-b42c-8c98d3ca5d09	2023-11-05	Warnings	Exact identifier ndc (package): 73168-004-00 ndc (product): 73168-004 ndc11 (package): 73168000400 spl id: 09751fc7-6657-c196-e063-6294a90a4a57 spl set id: fb78f705-b838-461d-b42c-8c98d3ca5d09

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.