Satohap Cool Type Lotion
FDA Label NDC 49873-620

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sato Pharmaceutical Co., Ltd. for the product Satohap Cool Type (NDC 49873-620). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, user safety warnings, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

Carton (Satohlotcoolcart)

Carton (Satohlotcoolcart)

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