MENTHOL ROLL ON- pain relief gel liquid, extended release

MENTHOL ROLL ON by

Drug Labeling and Warnings

MENTHOL ROLL ON by is a Otc medication manufactured, distributed, or labeled by Medhome Pharma Inc, Shanghai Chuangshi Medical Technology (Group) Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Menthol 4% ...... Purpose: Topical Analgesic

Purpose

Topical Analgesic

Uses

Temporarily relieves muscle soreness and minor joint pains in the wrist, knees, ankle, back, neck, hips, shoulders, elbows.

Warnings

For external use only

Do not use

on wounds or damaged skin

with a heating pad or device

with other ointments, creams, sprays, or liniments

if you are allergic to any ingredients of this product

When using this product

use only as directed

avoid contact with the eyes, mucous membranes, or rashes

do not bandage tightly

Stop use ... if

skin reactions such as redness, swelling, blistering or other discomfort occur

symptoms persist for more than 7 days

... ask a doctor if

skin reactions such as redness, swelling, blistering or other discomfort occur

symptoms persist for more than 7 days

If pregnant or breast-feeding,

Ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN.

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

Directions

Adults and children 12 years of age and older:

Rub a thin film over affected areas not more than 4 times daily;

Message not necessary

Children under 12 years of age: Consult physician.

Wash hands after use with cool water.

Inactive ingredients

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, Isopropyl Myristate, Ilex Paraguariensis Leaf Extract, Silica, Triethanolamine, Vitamin E, Water

Questions or Comments:

cs@medhomegroup,com

Dosage

74 mL in 1 BOTTLE

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MENTHOL ROLL ON 
pain relief gel liquid, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84007-333
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.04 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
.ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)
GLYCERIN (UNII: PDC6A3C0OX)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
TROLAMINE (UNII: 9O3K93S3TK)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
FRANKINCENSE (UNII: R9XLF1R1WM)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
ALCOHOL 95% (UNII: 7528N5H79B)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84007-333-01	74 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/17/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	07/17/2024

Labeler - Medhome Pharma Inc (129936136)

Registrant - Medhome Pharma Inc (129936136)

Establishment
Name	Address	ID/FEI	Business Operations
Shanghai Chuangshi Medical Technology (Group) Co., Ltd.		546872672	manufacture(84007-333) , label(84007-333)