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  5. Label Information: Ultra Strength Pain Relief Balm

FDA Label for Ultra Strength Pain Relief Balm

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS  ACTIVE INGREDIENTS
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DIRECTIONS
    6. OTHER INFORMATION
    7. INACTIVE INGREDIENTS
    8. QUESTIONS OR COMMENTS? CALL 1-888-287-1915.
    9. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ultra Strength Pain Relief Balm Product Label

The following document was submitted to the FDA by the labeler of this product Alaina Healthcare Private Limited. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


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