Muscle Freeze Relief Gel
FDA Label NDC 66902-410

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Natural Essentials, Inc. for the product Muscle Freeze Relief (NDC 66902-410). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

SHAKE WELL

Children under 12 years of age: consult a doctor.

Active Ingredient

Menthol 3.7%

Purpose

Topical Analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with:

  • Simple backache
  • Arthritis
  • Strains
  • Bruises
  • Sprains

Warnings

For external use only.

Flammable: Keep away from fire or flame and heated surfaces

Do Not Use

  • if you are allergic to any ingredient in this product
  • on open wounds, damaged or irriated skin
  • with a heating pad or TENS device
  • after expiration date

When Using This Product

  • do not bandage tightly
  • do not use otherwise than as directed
  • avoid contact with eyes or mucous membranes

Stop Use And Ask A Doctor If

  • condition worsens
  • rash, itching, redness or excessive irritation of the skin develops
  • symptoms persist for more than 7 days
  • symptoms dear up and occur again within a few days

Otc - Pregnancy Or Breast Feeding

If pregnant or breastfeeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

Adults And Children 12 Years Of Age And Over:

  • apply to affected area no more than 4 times a day
  • massage painful area until absorbed into skin
  • wash hands after each use with cold water

Other Information

  • store in a cool place away from direct sunlight
  • store with cap closed tightly

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Arnica Extract, Camphor, Carbomer, Ethylhexylglycerin, Ilex Paraguariensis leaf Extract, Isopropyl Alcohol, Phenoxyethanol, Tea Tree Oil, Tocopheryl Acetate (Vitamin E Acetate), Triethanolamine, Water.

Principal Display Panel – 85 G Container Label

Muscle
Freeze
Relief Gel

Net Wt. 3 oz. (85 g)

Principal Display Panel – 85 G Container Label (Mus05 0000 01)

Principal Display Panel – 85 G Container Label (Mus05 0000 01)

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