Wtyextrnlanglscoil

Wtyextrnlanglscoil
SPL v3
SPL
SPL Set ID 0b4bd444-b3c1-47aa-a7e3-f16c92326124
Route
TOPICAL
Published
Effective Date 2017-12-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (1 mg) Menthol (1.6 mg) Salicylic Acid (5 mg)
Inactive Ingredients
Lavender Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2011-11-15

Description

Camphor 10% Menthol 16% Methyl Salicylate 50%

Purpose

External Analgesic


Medication Information

Purpose

External Analgesic

Description

Camphor 10% Menthol 16% Methyl Salicylate 50%

Uses

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

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

Do not use

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

Directions
  • adults and children above 3 years of age: apply 3 to 4 drops of medicated oil to the affected area 1 to 2 times daily. After applying the product, a warm pad may be placed on the affected area for 10 minutes and then massaged as shown in the illustrations.
  • children under 3 years of age: consult your physician.
  • refer to the above warnings; use otherwise than as directed may be dangerous.



Package Label

Other Information
  • store at 16 to 30°C (61 to 86°F)
  • preserve in tight container

Active Ingredients

Camphor 10%



Menthol 16%



Methyl Salicylate 50%



Inactive Ingredients

Lavender oil









When Using This Product
  • avoid contact with the eyes or mucous membranes
  • do not bandage tightly

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
Keep Out of Reach of Children

to avoid accidental poisoning. If swallowed, get medical help or contact Poison Control Center right away


Structured Label Content

Uses

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

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

External Analgesic

Warnings

Do not use

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

Directions
  • adults and children above 3 years of age: apply 3 to 4 drops of medicated oil to the affected area 1 to 2 times daily. After applying the product, a warm pad may be placed on the affected area for 10 minutes and then massaged as shown in the illustrations.
  • children under 3 years of age: consult your physician.
  • refer to the above warnings; use otherwise than as directed may be dangerous.



Package Label

Other Information
  • store at 16 to 30°C (61 to 86°F)
  • preserve in tight container

Active Ingredients

Camphor 10%



Menthol 16%



Methyl Salicylate 50%



Inactive Ingredients

Lavender oil









When Using This Product (When using this product)
  • avoid contact with the eyes or mucous membranes
  • do not bandage tightly

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

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)

to avoid accidental poisoning. If swallowed, get medical help or contact Poison Control Center right away


Advanced Ingredient Data


Raw Label Data

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