Health One Deep Relieving Gel Cream
FDA Label NDC 55629-028

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by One2zee Limited Liability Company for the product Health One Deep Relieving Gel (NDC 55629-028). 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 drug facts:, active ingredients:, purpose, uses, warnings, allergy alert:, flammable:, do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts:

Active Ingredients:

Camphor 3.1%

Menthol 10.0%

Methyl Salicylate 15.0%

Purpose

Topical analgesic

Uses

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

  • simple backache
  • sprains
  • strains
  • arthritis
  • bruises

Warnings

For external use only

Allergy Alert:

If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

Flammable:

Keep away from fire or flame.

Do Not Use

  • on wounds or damaged skin
  • with a heating pad
  • if you are allergic to any ingredients of this product

When Using This Product

  • use only as directed
  • avoid contact with the eyes, mucous membranes or rashes
  • do not bandage tightly

Stop Use And Ask A Doctor If

  • conditions worsen
  • skin reactions such are redness, itching, rash, excessive irritation, burning sensation, swelling or blistering occur
  • symptoms persist for more than 7 days
  • symptoms 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.

Directions

Adults and children 12 years of age and over:

  • clean and dry affected area
  • apply a dime sized portion to the affected area
  • massage thoroughly until absorbed into skin
  • apply to affected area not more than 3 to 4 times daily

    • Children under 12 years of age: consult a doctor

Other Information

  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture
  • Store at 20-25C (68-77F)
  • Store with lid closed tightly

Inactive Ingredients

Ammonium Acryloyldimethyltaurate, VP Copolymer, Dimethyl Isosorbide, Propylene Glycol, Isopropyl Alcohol, Purified Water

Questions Or Comments?

1-833-663-2933

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