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  5. Label Information: Salonpas Pain Relieving Hot-l

FDA Label for Salonpas Pain Relieving Hot-l

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. WHEN USING THIS PRODUCT
    7. STOP USE AND ASK A DOCTOR IF
    8. IF PREGNANT OR BREAST-FEEDING,
    9. KEEP OUT OF REACH OF CHILDREN.
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS OR COMMENTS?
    14. PRINCIPAL DISPLAY PANEL

Salonpas Pain Relieving Hot-l Product Label

The following document was submitted to the FDA by the labeler of this product Hisamitsu Pharmaceutical Co., Inc.. 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



Capsicum extract   0.025% as Capsaicin

Menthol 1.25%


Purpose



Topical analgesic


Uses



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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings



For external use only


Do Not Use



  • on wounds or damaged skin
  • with a heating pad
  • if you are allergic to any ingredients of this product

When Using This Product



  • do not use otherwise than as directed
  • avoid contact with the eyes, mucous membranes or rashes
  • do not bandage tightly
  • discontinue use at least 1 hour before a bath or shower
  • do not use immediately after a bath or shower

Stop Use And Ask A Doctor If



  • rash, itching or excessive skin irritation develops
  • conditions worsen
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days

If Pregnant Or Breast-Feeding,



ask a health professional before use.


Keep Out Of Reach Of Children.



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


Directions



Adults and children 12 years of age and over:

  • clean and dry affected area
  • remove film from patch and apply to the skin (see illustration)
  • apply to affected area not more than 3 to 4 times daily
  • remove patch from the skin after at most 8 hours' application

    • Children under 12 years of age: consult a doctor


Other Information



  • avoid storing product in direct sunlight
  • protect product from excessive moisture

Inactive Ingredients



aluminum silicate, edetate disodium, gelatin, glycerin, magnesium aluminometasilicate, oleyl alcohol, polyacrylic acid, polyethylene glycol, polyvinyl alcohol, sodium polyacrylate, sorbitan monooleate, tartaric acid, titanium dioxide, water


Questions Or Comments?



Toll free 1-800-826-8861  www.salonpas.us


Principal Display Panel



LARGE

NDC#46581-890-03

for minor aches and pain relief

  • Shoulder
  • Upper Back
  • Lower Back

    • Salonpas pain relieving GEL-PATCH HOT-L

    Capsaicin 0.025%

    Menthol 1.25%

    LASTS UP TO 8 HOURS

    Pain Relieving Ointment on a Breathable Cloth

    STRETCHABLE

    3 patches

    3 15/16 X 7 7/8 (10cm X 20cm)

    Hisamitsu

    image of 3-patch box label - 4658189003 3

    image of 3-patch box label - 4658189003 3


* Please review the disclaimer below.