Joint & Muscle Pain Cream

Joint & Muscle Pain Cream
SPL v5
SPL
SPL Set ID 3943824f-1f4f-4d6f-bd73-0b1be02162a5
Route
TOPICAL
Published
Effective Date 2019-12-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (50 mg)
Inactive Ingredients
Water Propanediol Isononyl Isononanoate Cetostearyl Alcohol Ethylhexyl Palmitate Almond Oil Phenoxyethanol Stearic Acid Arginine Cetearyl Glucoside Carbomer Homopolymer, Unspecified Type Polysorbate 60 Caprylyl Glycol Xanthan Gum Tocopherol Ethylhexylglycerin Aloe Vera Leaf Glycerin Ginger

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-01-01

Description

Menthol (5%)

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Menthol (5%)

Uses

Provides penetrating temporary relief for minor pain in muscles and joints associated with:

  • Backache
  • Arthritis
  • Bruises
  • Sprains
Warnings

For external use only.

Directions

Apply generously to affected area. Massage well into painful area. Repeat as necessary, but not more than 3 to 4 times daily. Adults and children over the age of 2:

Do not use; consult a physician. Children under the age of 2:

Do Not Use
  • with a heating pad. Do not apply to wounds or damaged skin. Do not bandage tightly after use.
  • Avoid contact with eyes.
  • Discontinue use and consult a physician if condition worsens, or if symptoms persist more than 7 days or clear up and occur again within a few days.
Active Ingredient

Menthol (5%)

Package Labeling:

Inactive Ingredients

Water, Propanediol, Isononyl Isononanoate, Cetearyl Alcohol, Ethylhexyl Palmitate, Prunus Amygdalus Dulcis (Sweet Almond) Oil 1%, Phenoxyethanol, Stearic Acid, Arginine, Cetearyl Glucoside, Carbomer, Polysorbate 60, Caprylyl Glycol, Xanthan Gum, Tocopherol, Ethylhexylglycerin, Aloe Barbadensis Leaf Juice, Glycerin, Zingiber Officinale (Ginger) Root Extract.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a poison control center right away.


Structured Label Content

Uses

Provides penetrating temporary relief for minor pain in muscles and joints associated with:

  • Backache
  • Arthritis
  • Bruises
  • Sprains
Purpose

Topical Analgesic

Warnings

For external use only.

Directions

Apply generously to affected area. Massage well into painful area. Repeat as necessary, but not more than 3 to 4 times daily. Adults and children over the age of 2:

Do not use; consult a physician. Children under the age of 2:

Do Not Use (Do not use)
  • with a heating pad. Do not apply to wounds or damaged skin. Do not bandage tightly after use.
  • Avoid contact with eyes.
  • Discontinue use and consult a physician if condition worsens, or if symptoms persist more than 7 days or clear up and occur again within a few days.
Active Ingredient

Menthol (5%)

Package Labeling:

Inactive Ingredients

Water, Propanediol, Isononyl Isononanoate, Cetearyl Alcohol, Ethylhexyl Palmitate, Prunus Amygdalus Dulcis (Sweet Almond) Oil 1%, Phenoxyethanol, Stearic Acid, Arginine, Cetearyl Glucoside, Carbomer, Polysorbate 60, Caprylyl Glycol, Xanthan Gum, Tocopherol, Ethylhexylglycerin, Aloe Barbadensis Leaf Juice, Glycerin, Zingiber Officinale (Ginger) Root Extract.

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

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