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  5. Label Information: Kofal

FDA Label for Kofal

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS & PURPOSE
    2. OTC - ACTIVE INGREDIENT
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. STOP USE AND ASK DOCTOR IMMEDIATELY IF
    7. IF PREGNANT OR BREAST-FEEDING,
    8. KEEP OUT OF REACH OF CHILDREN.
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. QUESTIONS OR COMMENTS?
    13. DISTRIBUTED BY/ DISTRIBUIDO POR:
    14. PACKAGE LABEL & PRINCIPAL DISPLAY PANEL

Kofal Product Label

The following document was submitted to the FDA by the labeler of this product Pharmadel Llc. 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.

Active Ingredients & Purpose



Purpose

External Analgesic


Otc - Active Ingredient



Active ingredient Purpose
Methyl Salicylate 10.5%.............................External Analgesic


Uses



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

  • simple backache
  • arthritis
  • strains
  • sprains

Warnings



For external use only. Avoid contact with the eyes.


Do Not Use



  • on broken or irritated skin
  • with a tight bandage
  • with a heating pad

Stop Use And Ask Doctor Immediately If



  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • excessive skin irritation occurs

If Pregnant Or Breast-Feeding,



ask a health care professional before use.


Keep Out Of Reach Of Children.



If swallowed get medical help, or contact a Poison Control Center immediately.


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

Other Information



  • store between 59° to 86°F (15° to 25°C)
  • do not use if seal over cap is broken, torn or missing

Inactive Ingredients



camphor, menthol, methylparaben, paraffin wax, petrolatum, propylparaben.


* Please review the disclaimer below.