Ultra Strength Pain Relief Balm Ointment
FDA Label NDC 73492-711

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Alaina Healthcare Private Limited for the product Ultra Strength Pain Relief Balm (NDC 73492-711). 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, directions, other information, inactive ingredients, questions or comments? call 1-888-287-1915., 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 11%

Menthol 11%

Purpose

Camphor-Topical Analgesic
Menthol-Topical Analgesic

Uses

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

Warnings

For external use only.

When using this product

  • Use only as directed.
  • avoid contact with eye and mucous membranes.
  • do not apply to wounds, damaged or irritated skin.
  • do not bandage or cover with wrap or heating pad.
  • do not use 1 hour prior to bathing or within 30 minutes after bathing.

    • Stop use and ask a doctor if

    • condition worsens.
    • severe skin irritation occurs.
    • pain persists for more than 7 days.
    • pain clears up and then recurs a few days later.

      • If pregnant or breast-feeding, or if you have sensitive skin, ask a healthcare professional before use.

Directions

  • for adults and children over 12 years: rub well on the affected area. Repeat 3 to 4 times daily.
  • for children 12 years of age or younger: consult a doctor before use.

Other Information

This product may cause allergic reaction on some individuals. Test on a small area before use.

Inactive Ingredients

cajuput oil, cassia oil, clove oil, dementholized mint oil, paraffin base.

Questions Or Comments? Call 1-888-287-1915.

Package Label.Principal Display Panel

Ultra Strength Pain Relief Balm 0.63oz NDC- 73492-711-18-Label

Ultra Strength Pain Relief Balm 0.63oz Ndc- 73492-711-18-carton (Pain Relief Balm Bottle)

Ultra Strength Pain Relief Balm 0.63oz Ndc- 73492-711-18-carton (Pain Relief Balm Bottle)

Ultra Strength Pain Relief Balm 0.63oz NDC - 73492-711-18-Carton

Ultra Strength Pain Relief Balm 0.63oz Ndc- 73492-711-18-label (Pain Relief Balm Mono)

Ultra Strength Pain Relief Balm 0.63oz Ndc- 73492-711-18-label (Pain Relief Balm Mono)

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