OWELL NATURALS DEEP PENETRATING PAIN RELIEF- menthol ointment

OWELL NATURALS Deep Penetrating Pain Relief by

Drug Labeling and Warnings

OWELL NATURALS Deep Penetrating Pain Relief by is a Otc medication manufactured, distributed, or labeled by OWELL NATURALS BRAND, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Menthol 7.66%

Purpose

Topical Analgesic

Uses:

• For the temporary relief of minor aches and pains of muscles and joints, associated with simple backache, arthritis, strains, bruises, and sprains. 
• Provides cooling pain relief.

Warnings

For External Use Only.

Do Not Use

• on damaged or broken skin.

When using this product

• keep out of eyes. Rinse with water to remove
• Do not bandage tightly.

Stop use and ask a doctor if

• rash or irritation develops and lasts.
• condition worsens, or if 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.

If pregnant or breast-feeding,

ask a health professional before use.

Directions:

• Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. 
• Children under 2 years of age: consult a doctor.

Other information:

• Protect the product in this container from excessive heat and direct sun.

Inactive ingredients:

Camphor, Eucalyptus Globulus Oil, Methyl Salicylate, Petrolatum, Pinus Palustris Pine) Oil

Questions?

Customer Care: 1.800.203.9451

Package Labeling: 60ml

Package Labeling: 103.5ml

Package Labeling: 207ml

Package Labeling: 414ml

INGREDIENTS AND APPEARANCE

OWELL NATURALS DEEP PENETRATING PAIN RELIEF 
menthol ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83570-443
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	76.6 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
EUCALYPTUS OIL (UNII: 2R04ONI662)
METHYL SALICYLATE (UNII: LAV5U5022Y)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83570-443-02	60 mL in 1 JAR; Type 0: Not a Combination Product	01/08/2024
2	NDC: 83570-443-03	103.5 mL in 1 JAR; Type 0: Not a Combination Product	01/08/2024
3	NDC: 83570-443-07	207 mL in 1 JAR; Type 0: Not a Combination Product	01/08/2024
4	NDC: 83570-443-14	414 mL in 1 JAR; Type 0: Not a Combination Product	01/08/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	01/08/2024

Labeler - OWELL NATURALS BRAND, LLC (122280778)