Medicated Chest Rub

Medicated Chest Rub
SPL v2
SPL
SPL Set ID 6f8c45f2-8b47-4696-bd68-d327a48bb21b
Route
TOPICAL
Published
Effective Date 2011-07-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (4.8 g) Menthol (2.6 g) Eucalyptus Oil (1.2 g)
Inactive Ingredients
Cedar Leaf Oil Nutmeg Oil Paraffin Petrolatum Thymol Turpentine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-07-19

Description

Active ingredients Camphor 4.8% Menthol 2.6% Eucalyptus Oil 1.2%


Medication Information

Warnings and Precautions

Warnings

For external use only. Avoid contact with eyes

Indications and Usage

Uses: Temporarily relieves throat and chest

  • cough
  • nasal congestion due to common cold
  • aching muscles
  • minor aches and pains
Dosage and Administration

Directions

  • see important warnings when using this product
  • children under 2 years of age, ask a doctor before using this product
  • adults and children 2 years older, rub a thick layer on chest and and throat or rub on sore,aching muscles. If desired cover with a dry soft cloth but keep clothing loose. Repeat up to 3 times daily
Description

Active ingredients Camphor 4.8% Menthol 2.6% Eucalyptus Oil 1.2%

Section 42229-5

Other information

  • Store at room temperature
Section 50565-1

Keep out reach of children.

In case of accidental ingestion get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if

  • muscle aches/pain persist more than more than 7 days or come back
  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.
Section 50567-7
When using this product do not heat
  • microwave
  • use near open flame
  • add to hot water or any container where heating water may cause splattering and result in burns
Section 50569-3

Ask a doctor before use if you have

  • asthma
  • excessive phlem (mucus)
  • emphysema
  • persistent or chronic cough
  • cough associated with smoking
Section 50570-1

Do not use:

  • by mouth
  • by nostrils
  • on wounds or damaged skin
  • with light bandages
Section 51727-6

Inactive ingredients:

cedar leaf oil, nutmeg oil, paraffin, patrolatum, thymol, turpentine oil

Section 51945-4

Medicated chest rub



4 oz (113 g)









Section 53414-9

If pregnant or breast feeding, ask a health profesional before use

Section 55105-1

Purpose

Cough suppressant /topical analgesic

Cough suppressant /topical analgesic

Cough supressan

Section 55106-9

Active ingredients

Camphor 4.8%

Menthol 2.6%

Eucalyptus Oil 1.2%


Structured Label Content

Indications and Usage (34067-9)

Uses: Temporarily relieves throat and chest

  • cough
  • nasal congestion due to common cold
  • aching muscles
  • minor aches and pains
Dosage and Administration (34068-7)

Directions

  • see important warnings when using this product
  • children under 2 years of age, ask a doctor before using this product
  • adults and children 2 years older, rub a thick layer on chest and and throat or rub on sore,aching muscles. If desired cover with a dry soft cloth but keep clothing loose. Repeat up to 3 times daily
Warnings and Precautions (34071-1)

Warnings

For external use only. Avoid contact with eyes

Section 42229-5 (42229-5)

Other information

  • Store at room temperature
Section 50565-1 (50565-1)

Keep out reach of children.

In case of accidental ingestion get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • muscle aches/pain persist more than more than 7 days or come back
  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.
Section 50567-7 (50567-7)
When using this product do not heat
  • microwave
  • use near open flame
  • add to hot water or any container where heating water may cause splattering and result in burns
Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • asthma
  • excessive phlem (mucus)
  • emphysema
  • persistent or chronic cough
  • cough associated with smoking
Section 50570-1 (50570-1)

Do not use:

  • by mouth
  • by nostrils
  • on wounds or damaged skin
  • with light bandages
Section 51727-6 (51727-6)

Inactive ingredients:

cedar leaf oil, nutmeg oil, paraffin, patrolatum, thymol, turpentine oil

Section 51945-4 (51945-4)

Medicated chest rub



4 oz (113 g)









Section 53414-9 (53414-9)

If pregnant or breast feeding, ask a health profesional before use

Section 55105-1 (55105-1)

Purpose

Cough suppressant /topical analgesic

Cough suppressant /topical analgesic

Cough supressan

Section 55106-9 (55106-9)

Active ingredients

Camphor 4.8%

Menthol 2.6%

Eucalyptus Oil 1.2%


Advanced Ingredient Data


Raw Label Data

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