OWELL NATURALS PAIN RELIEF CREAM- menthol cream

Owell Naturals Pain Relief Cream by

Drug Labeling and Warnings

Owell Naturals Pain Relief Cream by is a Otc medication manufactured, distributed, or labeled by Owell Naturals Brand LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Menthol 8%

PURPOSE

Topical Analgesic

INDICATIONS & USAGE

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

WARNINGS

Warnings
For External Use Only.
Allergy Alert: If prone to allergic reaction from aspirin or salicylate, consult your doctor before using.
Do Not Use
■ on wounds or damaged skin ■ with a heating pad
■ on a child under 12 years of age with arthritis-like conditions
Ask a doctor before use if you have redness over the affected area.
When Using This Product ■ avoid contact with eyes or other sensitive areas ■ do not bandage tightly

Stop use and ask a doctor if
■ condition worsens or symptoms persist for more than 7 days
■ symptoms clear up and occur again within a few days
■ excessive skin irritation occurs
Keep out of reach of children to avoid accidental ingestion. If swal- lowed, get medical help or contact
a Poison Control Center immediately.

DOSAGE & ADMINISTRATION

Directions ■ use only as directed
■ adults and children 12 years of age and older: apply to affected area
■ children under 12 years of age: ask a doctor

INACTIVE INGREDIENT

Inactive ingredients Water, Carthamus tinctorius (Hybrid Safflower) Seed Oil, Helianthus annuus (Sunflower) Seed Oil, Cetyl PEG/PPG-10/1 Dimethicone, Aloe barbadensis (Aloe Vera) Leaf Juice, Beeswax, Hydro- genated Castor Oil, Caprylyl Glycol, Phenoxyethanol, Eucalyptus globulus Leaf Oil, Chlorphenesin, Cinnamomum camphora Bark Oil, Abies sibirica Needle Oil, Methyl Salicylate, Sodium Chloride

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children to avoid accidental ingestion. If swallowed, get medical help or contact a Poison Control Center immediately.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

OWELL NATURALS PAIN RELIEF CREAM 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83570-500
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 mL

Inactive Ingredients
Ingredient Name	Strength
SUNFLOWER SEED OIL GLYCERETH-8 ESTERS (UNII: 358X17CAT0)
PEG-8 BEESWAX (UNII: 3C1QUF1TIR)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ABIES SIBIRICA LEAF OIL (UNII: XRY0V4VZKZ)
WATER (UNII: 059QF0KO0R)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
CINNAMOMUM CAMPHORA WHOLE (UNII: 0B27814T7X)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
METHYL SALICYLATE (UNII: LAV5U5022Y)
SAFFLOWER OIL (UNII: 65UEH262IS)
CHLORPHENESIN (UNII: I670DAL4SZ)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83570-500-02	60 mL in 1 JAR; Type 0: Not a Combination Product	09/20/2024
2	NDC: 83570-500-03	103.5 mL in 1 JAR; Type 0: Not a Combination Product	09/20/2024
3	NDC: 83570-500-07	207 mL in 1 JAR; Type 0: Not a Combination Product	09/20/2024
4	NDC: 83570-500-14	414 mL in 1 JAR; Type 0: Not a Combination Product	09/20/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	09/20/2024

Labeler - Owell Naturals Brand LLC (122280778)