Procure gel

Manufacturer: TWIN MED, LLC
Effective date: 2025-06-20
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-06-01 01:03:39

Label at a glance#

ProductProcure gel

Active ingredientMENTHOL

Label structure7 sections

Indications and uses

Temporarily relieves minor aches and pains of muscles and joints associated with: ■Simple backache Arthritis ■Strains ■Bruises ■Sprains

Dosage and administration

■Adults and children 2 years of age and older: rub a thin ﬁlm over affected area not more than 3 to 4 times daily ■Children under 2 years of age: consult a physician ■Wash hands after use with cool water

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 5%

Purpose

OTC - PURPOSE SECTION

Pain Relieving

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor aches and pains of muscles and joints associated with: ■Simple backache

Arthritis ■Strains ■Bruises ■Sprains

Warnings

WARNINGS SECTION

For external use only

Flammable:

SPL UNCLASSIFIED SECTION

Keep away from excessive heat or open flame.

When using this product:

OTC - WHEN USING SECTION

■Use only as directed

■Avoid contact with the eyes or on mucous membranes

■Do not apply to wounds or damaged skin

■Do not apply to irritated skin or if excessive irritation develops ■Do not bandage tightly or use with heating pad or device

Stop use and ask a doctor if:

OTC - STOP USE SECTION

■You experience pain, swelling or blistering of the skin

■Condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days

■Arthritis pain persists for more than 10 days or redness is present, or in conditions affecting children under 12 years of age

If pregnant or breast-feeding:

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use

Keep out of reach of children:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

■Adults and children 2 years of age and older: rub a thin ﬁlm over affected area not more than 3 to 4 times daily ■Children under 2 years

of age: consult a physician ■Wash hands after use with cool water

OTHER SAFETY INFORMATION

■Store at 20˚-25˚C (68˚-77˚F)

■Store in a cool dry place away from direct sunlight

Inactive Ingredients

INACTIVE INGREDIENT SECTION

: Aloevera Extract, Arctium Lappa Root (Burdock) Extract, Arnica Montana Flower Extract, Calendula Ofﬁcinalis Extract, Carbopol, FD&C Blue No. 1, FD&C Yellow No. 5, Glycerine, Green Tea Extract, Isopropyl Alcohol, Isopropyl Myristate, Silica, Triethanolamine, Vitamin E, Water

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display and Drug Fact Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
415975	menthol 5 % Topical Gel	PSN	4
415975	menthol 0.05 MG/MG Topical Gel	SCD	4
415975	menthol 5 % Topical Gel	SY	4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
55681-015-63	Procure gel	2.9 g in 1 POUCH	GEL	2.9	4
55681-015-65	Procure gel	113 g in 1 TUBE	GEL	113	4
55681-015-67	Procure gel	907 g in 1 BOTTLE, DISPENSING	GEL	907	4

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

Procure gel
MENTHOL
FD&C BLUE NO. 1
SILICON DIOXIDE
FD&C YELLOW NO. 5
ALOE VERA LEAF
ARCTIUM LAPPA ROOT
ARNICA MONTANA FLOWER
CALENDULA OFFICINALIS FLOWER
GREEN TEA LEAF
CARBOXYPOLYMETHYLENE
GLYCERIN
ISOPROPYL ALCOHOL
ISOPROPYL MYRISTATE
.ALPHA.-TOCOPHEROL
TROLAMINE
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55681-015	55681-015-65, 55681-015-67, 55681-015-63

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
FD&C BLUE NO. 1	H3R47K3TBD	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
FD&C YELLOW NO. 5	I753WB2F1M	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
ARCTIUM LAPPA ROOT	597E9BI3Z3	IACT
ARNICA MONTANA FLOWER	OZ0E5Y15PZ	IACT
CALENDULA OFFICINALIS FLOWER	P0M7O4Y7YD	IACT
GREEN TEA LEAF	W2ZU1RY8B0	IACT
CARBOXYPOLYMETHYLENE	0A5MM307FC	IACT
GLYCERIN	PDC6A3C0OX	IACT
ISOPROPYL ALCOHOL	ND2M416302	IACT
ISOPROPYL MYRISTATE	0RE8K4LNJS	IACT
.ALPHA.-TOCOPHEROL	H4N855PNZ1	IACT
TROLAMINE	9O3K93S3TK	IACT
WATER	059QF0KO0R	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
Procure gel	MENTHOL	TWIN MED, LLC	e69c0b68-d408-9fd2-e053-2a95a90ac934	2025-06-20	Warnings	Exact identifier ndc (package): 55681-015-67 ndc (package): 55681-015-65 ndc (package): 55681-015-63 ndc (product): 55681-015 ndc11 (package): 55681001565 ndc11 (package): 55681001563 ndc11 (package): 55681001567 spl id: 37fee14e-5d6c-e5c4-e063-6394a90a7d8f spl set id: e69c0b68-d408-9fd2-e053-2a95a90ac934

Reported adverse events (FAERS/openFDA)#

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