top medicated oil

top medicated oil
SPL v1
SPL
SPL Set ID eb440866-9a10-44ac-af1d-e76c4733325e
Route
topical
Published
Effective Date 2012-05-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
camphor (natural) (10 mL) menthol (16 mL) methyl salicylate (50 mL)
Inactive Ingredients
clove oil lavender oil turpentine oil

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2012-05-24

Purpose

External Analgesic

Description

Camphor 10% Menthol 16% Methyl Salicylate 50%


Medication Information

Warnings

For external use only

Uses

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

  • simple backache
  • strains
  • bruises
  • arthritis
  • sprains



Purpose

External Analgesic

Directions
  • adults and children 3 years of age and older: 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.

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

Inactive Ingredients
  • Clove Oil
  • Lavender Oil
  • Turpentine Oil

Description

Camphor 10% Menthol 16% Methyl Salicylate 50%

Section 50565-1

Keep out of reach of children

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
Section 50567-7

When using this product

  • avoid contact with the eyes or mucous membranes
  • do not bandage tightly
Section 50570-1


Do not use

  • on wounds
  • on irritated or damaged skin
  • otherwise than as directed
Top Medicated Oil



Active Ingredients

Camphor 10%

Menthol 16%

Methyl Salicylate 50%

Top Medicated Oil 1.7oz/50ml (67473 601 01)



Structured Label Content

Warnings

For external use only

Uses

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

  • simple backache
  • strains
  • bruises
  • arthritis
  • sprains



Purpose

External Analgesic

Directions
  • adults and children 3 years of age and older: 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.

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

Inactive Ingredients
  • Clove Oil
  • Lavender Oil
  • Turpentine Oil

Section 50565-1 (50565-1)

Keep out of reach of children

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
Section 50567-7 (50567-7)

When using this product

  • avoid contact with the eyes or mucous membranes
  • do not bandage tightly
Section 50570-1 (50570-1)


Do not use

  • on wounds
  • on irritated or damaged skin
  • otherwise than as directed
Top Medicated Oil



Active Ingredients

Camphor 10%

Menthol 16%

Methyl Salicylate 50%

Top Medicated Oil 1.7oz/50ml (67473 601 01) (Top Medicated Oil 1.7oz/50ml (67473-601-01))



Advanced Ingredient Data


Raw Label Data

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