JOINT AND MUSCLE PAIN RELIEF- menthol cream 
Allure Labs

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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Drug Facts

Active ingredient

Menthol 1.5%

Purpose

Topical analgesic

Uses

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

simple backache

arthritis

strains

bruises

sprains

Warnings

For external use only

Do not use

on wounds or damaged skin

When using this product

avoid contact with eyes

do not bandage tightly

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.

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

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 Information

Store in a cool, dry place away from light

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

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.

Joint & Muscle pain relief

JOINT AND MUSCLE PAIN RELIEF 
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4219
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62742-4219-21 in 1 CARTON09/08/2022
1NDC:62742-4219-157 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01509/08/2022
Labeler - Allure Labs (926831603)
Registrant - Allure Labs (926831603)
Establishment
NameAddressID/FEIBusiness Operations
Allure Labs926831603manufacture(62742-4219)

Revised: 9/2022
Document Id: e82f99fd-c2f0-686f-e053-2a95a90a1dc9
Set id: e82f99fd-c2ef-686f-e053-2a95a90a1dc9
Version: 1
Effective Time: 20220908
 
Allure Labs