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  5. Label Information: Satohap Cool Type

FDA Label for Satohap Cool Type

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - DO NOT USE
    6. OTC - WHEN USING
    7. OTC - STOP USE
    8. USER SAFETY WARNINGS
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DOSAGE & ADMINISTRATION
    11. OTHER SAFETY INFORMATION
    12. INACTIVE INGREDIENT
    13. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Satohap Cool Type Product Label

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

Otc - Active Ingredient



Active ingredients

Camphor

Menthol

Methyl salicylate


Otc - Purpose



Purpose

Camphor   External analgesic

Menthol   External analgesic

Methyl salicylate   External analgesic


Indications & Usage



Uses  Temporarily relieves minor aches and pains of muscles and joints due to:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings



Warnings

For external use only

Flammable: Keep away from fire or flame


Otc - Do Not Use



Do not use

  • on wounds
  • on irritated, broken, or damaged skin
  • otherwise than as directed

Otc - When Using



When using this product

  • avoid contact with the eyes or mucous membranes
  • do not bandage tightly and do not apply local heat (heating pads, lamps, hot water in bags or bottles) because doing so can increase the risk of serious burns

Otc - Stop Use



Stop use and ask a doctor if

  • condition worsens
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • excessive irritation of the skin develops
  • nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs
  • when using for pain of arthritis:
  •    pain persists for more than 10 days
  •    redness is present
  •    in conditions affecting children under 12 years of age
  • you experience pain, swelling, or blistering of the skin (this product should not cause pain or skin damage)


User Safety Warnings



Warning-Rare cases of serious burns have been reported to occur on the skin where OTC external analgesics were applied.  Read and follow all directions and warnings on this label.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children to avoid accidental poisoning.  If swallowed, get medical help or contact a Poison Control Center right away.


Dosage & Administration



Directions

  • adults and children 3 years of age and older: apply to the affected area not more than 3 to 4 times daily
  • children under 3 years of age:  consult your physician
  • refer to the above warnings; use otherwise than as directed may be dangersous

Other Safety Information



Other information

  • keep container tightly closed
  • store at room temperature (20° to 25° C or 68° to 77° F)

Inactive Ingredient



Inactive ingredients

alcohol, propylene glycol, water.


Package Label.Principal Display Panel




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