Satohap Lotion (cool Type)

Satohap Lotion (cool Type)
SPL v4
SPL
SPL Set ID fe07a00a-2699-44d3-887d-bd068948ad7b
Route
TOPICAL
Published
Effective Date 2019-01-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (5 g) Levomenthol (6 g) Salicylic Acid (10 g)
Inactive Ingredients
Alcohol Propylene Glycol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-01-10

Description

Active ingredients Camphor Menthol Methyl salicylate


Medication Information

Warnings and Precautions

Warnings

For external use only

Flammable: Keep away from fire or flame

Indications and Usage

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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Dosage and 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
Description

Active ingredients Camphor Menthol Methyl salicylate

Section 50565-1

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

Section 50566-9

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)

Section 50567-7

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
Section 50570-1

Do not use

  • on wounds
  • on irritated, broken, or damaged skin
  • otherwise than as directed
Section 51727-6

Inactive ingredients

alcohol, propylene glycol, water.

Section 51945-4

Section 54433-8

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.

Section 55105-1

Purpose

Camphor   External analgesic

Menthol   External analgesic

Methyl salicylate   External analgesic

Section 55106-9

Active ingredients

Camphor

Menthol

Methyl salicylate

Section 60561-8

Other information

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

Structured Label Content

Indications and Usage (34067-9)

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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Dosage and Administration (34068-7)

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
Warnings and Precautions (34071-1)

Warnings

For external use only

Flammable: Keep away from fire or flame

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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)

Section 50567-7 (50567-7)

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
Section 50570-1 (50570-1)

Do not use

  • on wounds
  • on irritated, broken, or damaged skin
  • otherwise than as directed
Section 51727-6 (51727-6)

Inactive ingredients

alcohol, propylene glycol, water.

Section 51945-4 (51945-4)

Section 54433-8 (54433-8)

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.

Section 55105-1 (55105-1)

Purpose

Camphor   External analgesic

Menthol   External analgesic

Methyl salicylate   External analgesic

Section 55106-9 (55106-9)

Active ingredients

Camphor

Menthol

Methyl salicylate

Section 60561-8 (60561-8)

Other information

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

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)