PRO COLD HOT PAIN RELIEF GEL ROLL-ON (PLANTAR FASCIITIS)- menthol gel

PRO COLD HOT Pain Relief Gel Roll-On (Plantar Fasciitis) by

Drug Labeling and Warnings

PRO COLD HOT Pain Relief Gel Roll-On (Plantar Fasciitis) by is a Otc medication manufactured, distributed, or labeled by Guangzhou Zhupuyou E-commerce Co., Ltd, Shanghai Chuangshi Medical Technology (Group) Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Menthol 4%

PURPOSE

Topical Analgesic

INDICATIONS & USAGE

Temporary relieffrom minor aches and pains of sore muscles and joints associated with arthritisbackache, strains and sprains.

WARNINGS

For external use only

DO NOT USE

do not apply to wounds or damaged skin
do not use with other ointments, creams, sprays,
or liniments.
do not apply to irritated skin
do not bandage or use with heating pad or device

WHEN USING

use only as directed
avoid contact with eyes or mucous membranes
wash hands after use with cool water
store in a cool dry place away from direct sunlight

STOP USE

You experience pain, swelling or blistering; condition worsens, or if symptoms persist for morethan 7 days,or clear up and occur again within a few days.

KEEP OUT OF REACH OF CHILDREN

If swallowed accidentally, get medical help or contact with Poison Control Center immediately.

DOSAGE & ADMINISTRATION

Adults and Children above 12 years old:Rub a thin film over affected areas not more 4times daily; massage not necessary
Children under age of 12: Consult a doctor

INACTIVE INGREDIENT

Alcohol
Aloe barbadensis leaf extract
Arnica montana flower extract
Boswellia carterii resin extract
Camellia sinensis leaf extract
Carbomer
Camphor
FD&C Blue 1
FD&C Yellow 5
Glycerin
Ilex Paraguariensis Leaf Extract
Isopropyl Myristate
Silica
Triethanolamine
Vitamin E
Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PRO COLD HOT PAIN RELIEF GEL ROLL-ON (PLANTAR FASCIITIS) 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84165-013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL 95% (UNII: 7528N5H79B)
CARBOMER (UNII: 0A5MM307FC)
TRIETHANOLAMINE (UNII: 9O3K93S3TK)
.ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ALOE BARBADENSIS LEAF (UNII: ZY81Z83H0X)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
OLIBANUM (UNII: R9XLF1R1WM)
CAMELLIA SINENSIS LEAF (UNII: W2ZU1RY8B0)
WATER (UNII: 059QF0KO0R)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GLYCERIN (UNII: PDC6A3C0OX)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
SILICA (UNII: ETJ7Z6XBU4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84165-013-01	1 in 1 BOX	06/12/2025
1		74 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 84165-013-02	2 in 1 BOX	06/12/2025
2		74 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 84165-013-03	3 in 1 BOX	06/12/2025
3		74 mL in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 84165-013-04	4 in 1 BOX	06/12/2025
4		74 mL in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 84165-013-05	5 in 1 BOX	06/12/2025
5		74 mL in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC: 84165-013-06	6 in 1 BOX	06/12/2025
6		74 mL in 1 BOTTLE; Type 0: Not a Combination Product
7	NDC: 84165-013-07	7 in 1 BOX	06/12/2025
7		74 mL in 1 BOTTLE; Type 0: Not a Combination Product
8	NDC: 84165-013-08	8 in 1 BOX	06/12/2025
8		74 mL in 1 BOTTLE; Type 0: Not a Combination Product
9	NDC: 84165-013-09	9 in 1 BOX	06/12/2025
9		74 mL in 1 BOTTLE; Type 0: Not a Combination Product
10	NDC: 84165-013-10	10 in 1 BOX	06/12/2025
10		74 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	06/12/2025

Labeler - Guangzhou Zhupuyou E-commerce Co., Ltd (418214143)

Establishment
Name	Address	ID/FEI	Business Operations
Shanghai Chuangshi Medical Technology (Group) Co., Ltd.		546872672	manufacture(84165-013)