PROCURE GEL- menthol gel
TWIN MED, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55681-015
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:55681-015-65	113 g in 1 TUBE; Type 0: Not a Combination Product	08/19/2022
2	NDC:55681-015-67	907 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	08/19/2022
3	NDC:55681-015-63	2.9 g in 1 POUCH; Type 0: Not a Combination Product	09/19/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	09/19/2016

Labeler - TWIN MED, LLC (009579330)

Revised: 9/2022

Document Id: e819ab31-40ff-5bed-e053-2a95a90a307d

Set id: e69c0b68-d408-9fd2-e053-2a95a90ac934

Version: 2

Effective Time: 20220907

TWIN MED, LLC