Pain Away
FDA Label NDC 79804-265

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Eagle Labs Inc. for the product Pain Away (NDC 79804-265). 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 ingredient, pain relief - topical analgesic, indications, warnings, when usin this product, keep out of children, if pregnant or breastfeeding, flammable, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Capsacin; Analgesic

Menthol: Analgesic

Camphor: Analgesic

Pain Relief - Topical Analgesic

Analgesic

Indications

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

  • Simple backache
  • Arthritis
  • Strains
  • Bruises
  • Sprains

Warnings

  • For extrernal use only
  • Avoid Contact with the eyes
  • Do not apply to wounds or bandaged skin
  • Do not bandage tightly 

    • Stop use and consult a doctor if:

    • Condition worsens
    • Symptoms persist for more than 7 days or cleear up and reoccur
    • Redness is present
    • irritation develops

When Usin This Product

  • Use only as directed 
  • Do not apply heat (heating pads) or apply patches to area
  • do not use with other topical analgesics

Keep Out Of Children

If accidentally swallowed get medical help or contact a poison control center immediately

If Pregnant Or Breastfeeding

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

Keep out of the reach o children

If accidentally swallowed get medical help or contact a poison control center immediately

Flammable

Keep away from excessive heat or open flame

Inactive Ingredients

Isopropanol, MCT, Phenoxyethanol, Simethicone

Directions

Adults and children 12 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 12 years of age consult a doctor. 

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