JOINT AND MUSCLE PAIN RELIEF- menthol cream

Joint and Muscle Pain Relief by

Drug Labeling and Warnings

Joint and Muscle Pain Relief by is a Otc medication manufactured, distributed, or labeled by Allure Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Menthol 1.5%

PURPOSE

Purpose

Topical analgesic

INDICATIONS & USAGE

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with

simple backache

arthritis

strains

bruises

sprains

WARNINGS

Warnings

For external use only

DO NOT USE

Do not use

on wounds or damaged skin

WHEN USING

When using this product

avoid contact with eyes

do not bandage tightly

STOP USE

Stop use and ask a doctor if

condition worsens

irritation occurs

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION

Directions

Adults and children 2 years of age and olden Apply to affected area not more than 3 to 4 times daily Children under 2 years of age: ask a doctor

OTHER SAFETY INFORMATION

Other Information

Store in a cool, dry place away from light

If pregnant or breast-feeding, ask a health professional before use

INACTIVE INGREDIENT

Inactive Ingredients

Water, Glycerin,Cannabis Sativa Seed Oil, Arnica Montana Flower Extract, Glyceryl Stearates, Cetearyl Alcohol,Ceteareth-20,

PEG-100 Stearate,Butyrospermum Parkii (Shea) Butter, Cetyl Esters,Ammonium Acryloyldimethyltaurate/VP Copolymer,

Aloe Barbadensis Leaf Juice, Ethoxydiglycol, Dimethicone, Dipotassium Glycyrrhizate,Dimethyl Sulfone, Sodium Phytate,

Pyridoxine HCI, Methyl Gluceth-20, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Boswellia Carterii Oil,Menthe Piperita (Peppermint) Oil,Glucosamine HCI, Citric Acid, Phenoxyethanol,Potassium Sorbate,Sodium Benzoate, Ethylhexylglycerin,Tocopherol,

Monoglycerides,Sunflower Oil,Beta-Sitosterol, Squalene,Limonene, Linalool.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

JOINT AND MUSCLE PAIN RELIEF 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62742-4219
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM BENZOATE (UNII: OJ245FE5EU)
DIACETYLATED MONOGLYCERIDES (UNII: 5Z17386USF)
GLYCERIN (UNII: PDC6A3C0OX)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
PEG-100 STEARATE (UNII: YD01N1999R)
SHEA BUTTER (UNII: K49155WL9Y)
CETYL ESTERS WAX (UNII: D072FFP9GU)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
WATER (UNII: 059QF0KO0R)
PEPPERMINT OIL (UNII: AV092KU4JH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
TOCOPHEROL (UNII: R0ZB2556P8)
SUNFLOWER OIL (UNII: 3W1JG795YI)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
SQUALENE (UNII: 7QWM220FJH)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
METHYL GLUCETH-20 (UNII: J3QD0LD11P)
TEA TREE OIL (UNII: VIF565UC2G)
FRANKINCENSE OIL (UNII: 67ZYA5T02K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62742-4219-2	1 in 1 CARTON	09/08/2022
1	NDC: 62742-4219-1	57 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M015	09/08/2022

Labeler - Allure Labs (926831603)

Registrant - Allure Labs (926831603)

Establishment
Name	Address	ID/FEI	Business Operations
Allure Labs		926831603	manufacture(62742-4219)