nerve active pain relief cream

nerve active pain relief cream
SPL v2
SPL
SPL Set ID a8b85dcb-fd3e-4340-a945-609fc741443c
Route
topical
Published
Effective Date 2023-09-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (30 mg)
Inactive Ingredients
aloe vera leaf water arnica montana flower indian frankincense cetyl alcohol ethylhexylglycerin glyceryl monostearate glycyrrhiza glabra ilex paraguariensis leaf isopropyl myristate magnesium sulfate, unspecified form methyl salicylate polyethylene glycol 400 phenoxyethanol polysorbate 20 trolamine

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-09-18

Purpose

Topical Analgesic

Description

Menthol 3.00%


Medication Information

Purpose

Topical Analgesic

Description

Menthol 3.00%

Questions?

800-340-3418

Uses:
  • For the temporary relief of minor aches and pains of muscles and joints, associated with simple backache, arthritis, strains, bruises, and sprains.
Warnings:

For external use only

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.
Package Labeling:

Active Ingredients

Menthol 3.00%

Other Information:
  • Protect the product in this container from excessive head and direct sun.
Inactive Ingredients:

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cetyl Alcohol, Ethylhexylglycerin, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Extract, Ilex Paraguariensis (Yerba Mate’) Extract, Isopropyl Myristate, Magnesium Sulfate, Methyl Salicylate, PEG-8, Phenoxyethanol, Polysorbate-20, Triethanolamine.

When Using This Product
  • Avoid contact with the eyes.
  • 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 agani 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

Purpose

Topical Analgesic

Questions?

800-340-3418

Uses:
  • For the temporary relief of minor aches and pains of muscles and joints, associated with simple backache, arthritis, strains, bruises, and sprains.
Warnings:

For external use only

Do Not Use (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.
Package Labeling:

Active Ingredients

Menthol 3.00%

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

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cetyl Alcohol, Ethylhexylglycerin, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Extract, Ilex Paraguariensis (Yerba Mate’) Extract, Isopropyl Myristate, Magnesium Sulfate, Methyl Salicylate, PEG-8, Phenoxyethanol, Polysorbate-20, Triethanolamine.

When Using This Product (When using this product)
  • Avoid contact with the eyes.
  • Do not bandage tightly.
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 agani 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

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