1. Home
  2. Labeler Index
  3. Hisamitsu Pharmaceutical Co., Inc.
  4. 46581-700
  5. Label Information: Salonpas-hot Capsicum

FDA Label for Salonpas-hot Capsicum

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    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-hot Capsicum 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 Ingredient



Capsicum extract  0.025% as Capsaicin


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 patch from film
  • 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



butylated hydroxytoluene, hydrogenated rosin glycerol ester, maleated rosin glycerin ester, natural rubber latex, polybutene, polyisobutylene, silicon dioxide, titanium dioxide, zinc oxide


Questions Or Comments?



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


Principal Display Panel



NDC#46581-700-01

Hisamitsu

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

  • Simple backache
  • Arthritis
  • Strains
  • Bruises
  • Sprains

    • SALONPAS-HOT

    CAPSICUM PATCH

    Topical Analgesic

    1 PATCH

    5.12" X 7.09"


* Please review the disclaimer below.