PROCURE GEL- menthol gel 
TWIN MED, LLC

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PROCURE GREEN PAIN GEL

Drug Facts

Active Ingredients

Menthol 5%

Purpose

Pain Relieving

Uses

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

Arthritis ■Strains ■Bruises ■Sprains

Warnings

For external use only

Flammable:

Keep away from excessive heat or open flame.

When using this product:

■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:

■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:

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 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

■Store at 20˚-25˚C (68˚-77˚F)


■Store in a cool dry place away from direct sunlight

Inactive Ingredients

: 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:

Principal Display and Drug Fact Panel

PROCURE GEL 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55681-015
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55681-015-65113 g in 1 TUBE; Type 0: Not a Combination Product08/19/2022
2NDC:55681-015-67907 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product08/19/2022
3NDC:55681-015-632.9 g in 1 POUCH; Type 0: Not a Combination Product09/19/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01709/19/2016
Labeler - TWIN MED, LLC (009579330)

Revised: 1/2024
Document Id: 0e713b70-588e-b758-e063-6394a90a5b73
Set id: e69c0b68-d408-9fd2-e053-2a95a90ac934
Version: 3
Effective Time: 20240108
 
TWIN MED, LLC