Satohap Cool & Hot Pads - 5 Pads In 1 Pouch - (13cm By 8cm Each Pad)

Satohap Cool & Hot Pads - 5 Pads In 1 Pouch - (13cm By 8cm Each Pad)
SPL v4
SPL
SPL Set ID b6bf1eab-4ab9-f500-e053-2995a90a8d7b
Route
TOPICAL
Published
Effective Date 2020-12-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (3.1 g) Levomenthol (6 g) Capsaicin (0.025 g)
Inactive Ingredients
Acrylic Acid/sodium Acrylate Copolymer (1:1; 600 Mpa.s At 0.2%) 2-ethylhexyl Acrylate Methyl Acrylate Polysorbate 80 Carboxymethylcellulose Sodium Sorbitol Titanium Dioxide Aluminum Hydroxide Dihydroxyaluminum Aminoacetate Water Malic Acid Polyvinyl Alcohol, Unspecified Glycerin Talc Edetate Disodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-12-18

Description

Camphor 3.1% Capsaicin 0.025% Menthol 6%

Purpose

External analgesic External analgesic External analgesic


Medication Information

Purpose

External analgesic

External analgesic

External analgesic

Description

Camphor 3.1% Capsaicin 0.025% Menthol 6%

Uses

For the temporary relief of minor aches and pains of muscles and joints due to:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Warnings

For external use only

Directions
  • Adults and children 4 years of age and older: remove polyethylene film and place adhesive pad over affected area.
  • do not use more than 2 patches per day.
  • Children under 4 years of age: Consult a doctor.
Do Not Use
  • on irritated or damaged skin
  • on wounds
Other Information
  • keep pouch tightly closed
  • keep product protected from heat
Active Ingredients

Camphor 3.1%

Capsaicin 0.025%

Menthol 6%

Inactive Ingredients

carboxymethylcellulose sodium, dihydroxyaluminum aminoacetate, dried aluminum hydroxide gel, edetate disodium, emulsion of methyl acrylate and 2-ethylhexyl acrylate copolymer, glycerin, malic acid, partially neutralized polyacrylate, polysorbate 80, polyvinyl alcohol, sorbitol solution, talc, titanium dioxide, and water on a polyester fiber backing and covered with a polyethylene film.

Questions Or Comments?
  • contact Sato Pharmaceutical Inc. 20695 S. Western Ave., Suite 240, Torrence, CA 90501
  • you may also report serious side effects to this address
When Using This Product
  • avoid contact with the eyes or mucus membranes
  • do not bandage tightly
  • do not apply heat to the area in the form of heating pads, hot water bottles, or lamps (doing so increases the risk of serious burns)
Satohap Cool and Hot Pads

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.
  • you feel actual pain or experience blistering or burning after application (it is normal to feel a warming or cooling sensation)
  • when using for pain or arthritis:
  • pain persists for more than 10 days
  • redness is present
  • in conditions affecting children under 12 years of age
Keep Out of Reach of Children.

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

Ask A Doctor Or Pharmacist Before Use If You Have
  • any concerns about using this product

Structured Label Content

Uses

For the temporary relief of minor aches and pains of muscles and joints due to:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Purpose

External analgesic

External analgesic

External analgesic

Warnings

For external use only

Directions
  • Adults and children 4 years of age and older: remove polyethylene film and place adhesive pad over affected area.
  • do not use more than 2 patches per day.
  • Children under 4 years of age: Consult a doctor.
Do Not Use (Do not use)
  • on irritated or damaged skin
  • on wounds
Other Information (Other information)
  • keep pouch tightly closed
  • keep product protected from heat
Active Ingredients (Active ingredients)

Camphor 3.1%

Capsaicin 0.025%

Menthol 6%

Inactive Ingredients (Inactive ingredients)

carboxymethylcellulose sodium, dihydroxyaluminum aminoacetate, dried aluminum hydroxide gel, edetate disodium, emulsion of methyl acrylate and 2-ethylhexyl acrylate copolymer, glycerin, malic acid, partially neutralized polyacrylate, polysorbate 80, polyvinyl alcohol, sorbitol solution, talc, titanium dioxide, and water on a polyester fiber backing and covered with a polyethylene film.

Questions Or Comments? (Questions or comments?)
  • contact Sato Pharmaceutical Inc. 20695 S. Western Ave., Suite 240, Torrence, CA 90501
  • you may also report serious side effects to this address
When Using This Product (When using this product)
  • avoid contact with the eyes or mucus membranes
  • do not bandage tightly
  • do not apply heat to the area in the form of heating pads, hot water bottles, or lamps (doing so increases the risk of serious burns)
Satohap Cool and Hot Pads

Stop Use and Ask A Doctor If (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.
  • you feel actual pain or experience blistering or burning after application (it is normal to feel a warming or cooling sensation)
  • when using for pain or arthritis:
  • pain persists for more than 10 days
  • redness is present
  • in conditions affecting children under 12 years of age
Keep Out of Reach of Children. (Keep out of reach of children.)

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

Ask A Doctor Or Pharmacist Before Use If You Have (Ask a doctor or pharmacist before use if you have)
  • any concerns about using this product

Advanced Ingredient Data


Raw Label Data

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