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  5. Label Information: Cold Rub

FDA Label for Cold Rub

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - DO NOT USE
    6. OTC - ASK DOCTOR
    7. OTC - PREGNANCY OR BREAST FEEDING
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. DOSAGE & ADMINISTRATION
    10. OTHER
    11. INACTIVE INGREDIENT
    12. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cold Rub Product Label

The following document was submitted to the FDA by the labeler of this product Jmd All Star Impex Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active Ingredients
Camphor 4.8%
Eucalyptus oil 1.2%
Menthol 2.8%



Otc - Purpose



PURPOSE

cough suppressant/topical analgesic
nasal decongestant/cough suppressant
cough suppressant/topical analgesic


Indications & Usage



Uses

Temporarily relief for throat and chest

  • Cough 
  • Nasal congestion due to common cold
  • Aching muscles
  • Minor aches and pains

Warnings



WarningFor external use only. Avoid contact with eyes.

Otc - Do Not Use



Do not use
  • by mouth
  • in nostrils
  • on wounds or damaged skin
  • with light bandages

Otc - Ask Doctor



Ask a doctor before use if you have

  • Asthma
  • Excessive phlegm (mucus)
  • Emphysema
  • Persistent or chronic cough
  • Cough associated with smoking

Otc - Pregnancy Or Breast Feeding



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


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If case of accidental ingestion, get medical help or contact a Poison Control Center immediately.


Dosage & Administration



Directions

  • See important warnings under "When using product"
  • Children under 2 years of age, ask a doctor before using the product
  • Adults and children 2 years of age and older: rub a thick layer chest and throat or sore aching muscles. If desired loosely cover with a soft cloth but keep clothing loose. Repeat up to 3 times daily


Other



Other Information
  • Store at room temperature

Inactive Ingredient



Other IngredientsCedar leaf Oil, Mineral Oil, Nutmeg Oil, Petrolatum, Spirits of Turpentine, Thymol

Package Label.Principal Display Panel



Package Label

image of package label - coldrublbl

image of package label - coldrublbl


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