MENTHOL- owell naturals pain relief cream cream
Amish Origins LLC

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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Owell Naturals Pain Relief Cream

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

7FL OZ Pain Relief Cream label

MENTHOL
owell naturals pain relief cream cream

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

Labeler - Amish Origins LLC (079239259)