Phoenix Balm
FDA Label NDC 24438-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Amazonian Naturals, Inc. for the product Phoenix Balm (NDC 24438-001). 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 active ingredients, purposes, uses, warnings, when using this product, stop use and ask a doctor if, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Camphor 5%.................................... Topical Analgesic
Menthol 5% ..................................... Topical Analgesic
Methyl Salicylate 5%........................ Topical Analgesic

Purposes

Topical Analgesic

Uses

For temporary relief of minor aches and pains of muscles and joints associated with over-exertions, arthritis, strains and sprains.

Warnings

Warnings    For external use only.

When Using This Product

  • Avoid contact with eyes and mucous membranes.
  • Do not apply to open wounds or damaged skin.
  • Do not bandage or use heating pad.

Stop Use And Ask A Doctor If

  • Condition Worsens.
  • Severe skin irritation occurs.
  • Pain persists for more than seven days.
  • Pain clears up and then recurs a few days later.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding ask a health care professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.  If swallowed get medical help or contact a Poisen Control Center immediately.

Directions

  • Rub well on the affected area.  Repeat 2 or 3 times daily.
  • For children 2 - 12 years, consult a doctor before use.

Other Information

This product may cause allergic reaction in some people.  Test on small area before use.

Inactive Ingredients

Pine needle oil, Cats Claw and Paraffin Petrolatum

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