drug facts

drug facts
SPL v2
SPL
SPL Set ID d54be1a1-10e3-43ec-b54e-aa7bd7e8be20
Route
topical
Published
Effective Date 2012-08-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
camphor (synthetic) (4.8 g) eucalyptus oil (2.6 g) menthol (1.2 g)
Inactive Ingredients
nutmeg oil petrolatum thuja occidentalis bark thymol turpentine

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2012-08-15

Purpose

Cough suppressant and topical analgesic Cough suppressant Cough suppressant and topical analgesic

Description

Camphor 4.8% Eucalyptus Oil 1.2% Menthol 2.6%


Medication Information

Warnings

For external use only; avoid contact with eyes.

Uses
  • On chest and throat, temporarily relieves cough due to common cold

  • On muscles and joints, temporarily relieves minor aches and pains
Purpose

Cough suppressant and topical analgesic

Cough suppressant

Cough suppressant and topical analgesic

Directions

see important warnings under "When using this product"

  • adults and children 2 years and over:
  • Apply a thick layer on chest and throat or rub on sore aching muscles.
  • Cover with a warm, dry cloth if desired
  • Keep clothing loose about throat/chest to help vapors reach the nose/mouth
  • repeat up to 3 times per 24 hours or as directed by doctor
  • children under 2 years: do not use
Other Information
  • store at room temperature.

Inactive Ingredients

myristica fragrans (nutmeg) kernel oil, petrolatum, thuja occidentalis bark extract, thymol, turpentine

Description

Camphor 4.8% Eucalyptus Oil 1.2% Menthol 2.6%

Do Not Use
  • by mouth
  • with tight bandages
  • in nostrils
  • on wounds or damaged skin
Package Label

Vida Mia Chest Rub

Active Ingredients



Camphor 4.8%

Eucalyptus Oil 1.2%

Menthol 2.6%

Stop Use and Ask A Doctor If

  • muscle aches and pains persist more than 7 days or come back
  • cough lasts for more than 7 days, comes back or occurs with fever, rash or persistent headache.

    These could be signs of a serious condition.
If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

When Using This Product, Do Not
  • heat
  • microwave
  • add to hot water or any container where heating water.

May cause splattering and result in burns.
Ask A Doctor Before Use If You Have
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma or emphysema

Structured Label Content

Warnings

For external use only; avoid contact with eyes.

Uses
  • On chest and throat, temporarily relieves cough due to common cold

  • On muscles and joints, temporarily relieves minor aches and pains
Purpose

Cough suppressant and topical analgesic

Cough suppressant

Cough suppressant and topical analgesic

Directions

see important warnings under "When using this product"

  • adults and children 2 years and over:
  • Apply a thick layer on chest and throat or rub on sore aching muscles.
  • Cover with a warm, dry cloth if desired
  • Keep clothing loose about throat/chest to help vapors reach the nose/mouth
  • repeat up to 3 times per 24 hours or as directed by doctor
  • children under 2 years: do not use
Other Information (Other information)
  • store at room temperature.

Inactive Ingredients (Inactive ingredients)

myristica fragrans (nutmeg) kernel oil, petrolatum, thuja occidentalis bark extract, thymol, turpentine

Do Not Use (Do not use)
  • by mouth
  • with tight bandages
  • in nostrils
  • on wounds or damaged skin
Package Label (Package label)

Vida Mia Chest Rub

Active Ingredients (Active ingredients)



Camphor 4.8%

Eucalyptus Oil 1.2%

Menthol 2.6%

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

  • muscle aches and pains persist more than 7 days or come back
  • cough lasts for more than 7 days, comes back or occurs with fever, rash or persistent headache.

    These could be signs of a serious condition.
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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.

When Using This Product, Do Not (When using this product, do not)
  • heat
  • microwave
  • add to hot water or any container where heating water.

May cause splattering and result in burns.
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma or emphysema

Advanced Ingredient Data


Raw Label Data

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