satohap cool & hot - 5 pads in 1 pouch - (10cm by 7cm each pad)

satohap cool & hot - 5 pads in 1 pouch - (10cm by 7cm each pad)
SPL v1
SPL
SPL Set ID 232a4c76-1a0c-2f4b-e063-6394a90a8849
Route
topical
Published
Effective Date 2024-09-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
capsaicin (0.025 g) camphor (synthetic) (3.1 g) levomenthol (6 g)
Inactive Ingredients
titanium dioxide aluminum hydroxide malic acid polyvinyl alcohol, unspecified glycerin edetate disodium water 2-ethylhexyl acrylate dihydroxyaluminum aminoacetate talc acrylic acid/sodium acrylate copolymer (1:1; 600 mpa.s at 0.2%) methyl acrylate polysorbate 80 carboxymethylcellulose sodium sorbitol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-09-01

Purpose

External analgesic External analgesic External analgesic

Description

Camphor 3.1% Capsaicin 0.025% Menthol 6%


Medication Information

Warnings

For external use only

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

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.
Other Information
  • keep pouch tightly closed
  • keep product protected from heat
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.

Description

Camphor 3.1% Capsaicin 0.025% Menthol 6%

Do Not Use
  • on irritated or damaged skin
  • on wounds
Active Ingredients

Camphor 3.1%

Capsaicin 0.025%

Menthol 6%

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)
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 of 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.

Satohap Cool & Hot 10cm By 7cm

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

Structured Label Content

Warnings

For external use only

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

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.
Other Information (Other information)
  • keep pouch tightly closed
  • keep product protected from heat
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.

Do Not Use (Do not use)
  • on irritated or damaged skin
  • on wounds
Active Ingredients (Active ingredients)

Camphor 3.1%

Capsaicin 0.025%

Menthol 6%

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)
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 of 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.

Satohap Cool & Hot 10cm By 7cm (SATOHAP COOL & HOT 10cm BY 7cm)

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

All Sections (JSON)