MENTHOL- owell naturals pain relief cream cream

Menthol by

Drug Labeling and Warnings

Menthol by is a Otc medication manufactured, distributed, or labeled by Amish Origins LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Menthol 8%

Purpose

Topical Analgesic

Uses:

Arthritis Pain, Sore Joints and Muscles, Sore Throat, Sinus Trouble, Restless Leg Syndrome

Warnings

• For External Use Only, As Directed!
• Avoid contact with eyes or other sensitive areas.
• If prone to allergic reaction from asprin or salicylate, consult your doctor before using.
• If conditions persist pore than seven days, consult your doctor
• If pregnant or breast-feeding, ask a health professional before use.
• Do not bandange tightly or use a heating pad
• May irritate sensitive skin

• Keep ointment out of reach of children

Directions

​Adults and children over 12 years:

• ​Apply freely to affected areas. Rub well
• ​Colds: ​Apply on chest, back and neck.
• ​Head Colds: Apply around nostrils, on forehead and behind ears.  Place small amount in vaporizer for aid.
• ​Sore Throat:​ Apply  liberally on throat and neck for sore throats

Children 12 years or younger.

• Consult your physician.

INACTIVE INGREDIENTS

Water, Carthamus Tinctorius (Hybrid Safflower) Seed Oil, Cetyl PEG/PPG-10/1 Dimethicone, Aloe Barbadensis (Aleo Vera) Leaf Juice, Beeswax, Hydrogenated Castor oil, Caprylyl Glycol, Phenoxyethanol, Eucalyptus Globulus Leaf Oil, Chlorphenesin, Cinnamomum Camphora Bark Oil, Abies Sibirica Needle Oil, Methyl Salicylate, Sodium Chloride

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MENTHOL 
owell naturals pain relief cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62212-505
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	8 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SAFFLOWER OIL (UNII: 65UEH262IS)
SUNFLOWER SEED OIL GLYCERETH-8 ESTERS (UNII: 358X17CAT0)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
CINNAMOMUM CAMPHORA WHOLE (UNII: 0B27814T7X)
ABIES SIBIRICA LEAF OIL (UNII: XRY0V4VZKZ)
METHYL SALICYLATE (UNII: LAV5U5022Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62212-505-01	198.45 g in 1 JAR; Type 0: Not a Combination Product	07/17/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	07/17/2023

Labeler - Amish Origins LLC (079239259)