owell naturals deep penetrating pain relief ointment

owell naturals deep penetrating pain relief ointment
SPL v1
SPL
SPL Set ID b36eb017-ed8d-476e-994b-22b275e00543
Route
topical
Published
Effective Date 2023-12-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (76.6 mg)
Inactive Ingredients
eucalyptus oil methyl salicylate petrolatum

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-01-08

Purpose

Topical Analgesic

Description

Menthol 7.66%


Medication Information

Warnings

For External Use Only.

Purpose

Topical Analgesic

Description

Menthol 7.66%

Questions?

Customer Care: 1.800.203.9451

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.
Do Not Use
  • on damaged or broken skin.
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.
Active Ingredients

Menthol 7.66%

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

Package Labeling: 60ml

Package Labeling: 207ml
Package Labeling: 414ml
When Using This Product
  • keep out of eyes. Rinse with water to remove
  • Do not bandage tightly.
Package Labeling: 103.5ml

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.
If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

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


Structured Label Content

Warnings

For External Use Only.

Purpose

Topical Analgesic

Questions?

Customer Care: 1.800.203.9451

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.
Do Not Use
  • on damaged or broken skin.
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.
Active Ingredients

Menthol 7.66%

Other Information: (Other information:)
  • Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients: (Inactive ingredients:)

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

Package Labeling: 60ml

Package Labeling: 207ml
Package Labeling: 414ml
When Using This Product (When using this product)
  • keep out of eyes. Rinse with water to remove
  • Do not bandage tightly.
Package Labeling: 103.5ml

Stop Use and Ask A Doctor If (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.
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)