Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 7e16c0c8-8874-4de2-8bb2-1dc8173f9b08
Route
TOPICAL
Published
Effective Date 2012-04-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (12.5 mg)
Inactive Ingredients
Aloe Vera Leaf Cetyl Alcohol Cetyl Esters Wax Cinnamon Oil Eucalyptus Oil Glyceryl Monostearate Grape Seed Oil Hypromelloses Jojoba Oil Peppermint Oil Potassium Sorbate Water Squalane Stearic Acid Stearyl Alcohol Tea Tree Oil Glycerin Methyl Salicylate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-04-13

Description

Active  Ingredient Menthol 1.25%


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Use Temporarily relieves minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Dosage and Administration

Directions

  • Adult and children 12 years of age or older: Apply to affected area not more than 3 to 4 times daily.
  • Children under 12 years of age: Consult a physician.

Description

Active  Ingredient Menthol 1.25%

Section 50565-1
Keep out of reach of children.

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

Section 50566-9

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

Section 50567-7

Enter section text here

Section 50570-1

Do not use

  • on wounds or damaged skin

Section 51727-6

Inactive Ingredients: aloe vera gel, cetyl alcohol, cetyl esters (proprietary blend of esterfied fatty acids), cinnamon oil, eucalyptus oil, glyceryl stearate, grape seed oil, hypromellose, jojoba oil, peppermint oil, potassium sorbate, purified water, squalane, stearic acid, stearyl alcohol, tea tree oil, vegetable glycerin, wintergreen oil

Section 51945-4

North Star

Nutritionals



Paraben Free!



Arthritis Relief

Cream





Provides Penetrating

Joint Pain Relief





Pain Relieving Cream

Net Wt. 2 oz (57g)

Section 53413-1

Questions?  Contact (800) 895-2108.

Reorder Code: G650K2BT

Manufactured for and Distributed by NewMarket Health

Products, LLC.  702 Cathedral St. Baltimore, MD 21201 

Made in the USA from foreign and domestic ingredients.

Section 55105-1

Purpose

Topical Analgesic

Section 55106-9
Active  Ingredient

Menthol 1.25%


Structured Label Content

Indications and Usage (34067-9)

Use Temporarily relieves minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Dosage and Administration (34068-7)

Directions

  • Adult and children 12 years of age or older: Apply to affected area not more than 3 to 4 times daily.
  • Children under 12 years of age: Consult a physician.

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 50565-1 (50565-1)
Keep out of reach of children.

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

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

Enter section text here

Section 50570-1 (50570-1)

Do not use

  • on wounds or damaged skin

Section 51727-6 (51727-6)

Inactive Ingredients: aloe vera gel, cetyl alcohol, cetyl esters (proprietary blend of esterfied fatty acids), cinnamon oil, eucalyptus oil, glyceryl stearate, grape seed oil, hypromellose, jojoba oil, peppermint oil, potassium sorbate, purified water, squalane, stearic acid, stearyl alcohol, tea tree oil, vegetable glycerin, wintergreen oil

Section 51945-4 (51945-4)

North Star

Nutritionals



Paraben Free!



Arthritis Relief

Cream





Provides Penetrating

Joint Pain Relief





Pain Relieving Cream

Net Wt. 2 oz (57g)

Section 53413-1 (53413-1)

Questions?  Contact (800) 895-2108.

Reorder Code: G650K2BT

Manufactured for and Distributed by NewMarket Health

Products, LLC.  702 Cathedral St. Baltimore, MD 21201 

Made in the USA from foreign and domestic ingredients.

Section 55105-1 (55105-1)

Purpose

Topical Analgesic

Section 55106-9 (55106-9)
Active  Ingredient

Menthol 1.25%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)