Earths Best Cold Relief Vapor
FDA Label NDC 61995-0758

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by The Hain Celestial Group, Inc for the product Earths Best Cold Relief Vapor (NDC 61995-0758). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, inactive ingredient, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Camphor                                   5.3%

Menthol                                     2.8%

Eucalyptus Globulus Leaf Oil      1.3%

Otc - Purpose

Natural Skin Protectant

Indications & Usage

  • Temporarily relieves cough due to common cold
  • On muscles and joints, temporarily relieves minor aches and pains

Warnings

For external use only. Avoid contact with eyes. Do not take by mouth or place in nostrils. Ask a doctor before use if you have cough with too much phlegm (mucus)or persistent or chronic cough such asthma. 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.  Stop use and ask doctor if  muscle aches and pains persist more than 7days or come back,cough lasts more than 1 week, comes back or occurs with fiver, rash or persistent headache. There could be signs of serious condition. If pregnant or breastfeeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed get medical help or contact Poison Center right away.

Dosage & Administration

See important warnings under "When using this product". Adults and children 2 years old and older:
  • Rub over chest and throat in a thick layer or rub on aching muscles.
  • Cover with warm dry cloth if desired.
  • Keep clothing loose around chest and throat  to help vapors to reach nose and mouth.
  • Use up to 3 times per day or as directed by doctor. Children under 2 years of age : Ask a doctor.

Inactive Ingredient

Helianthus Annuus (Sunflower) Seed Oil *, Beeswax*, Mentha Piperita (Peppermint) Oil*

* Certified Organic Ingredients

Otc - Questions

Questions? Visit  www.earthsbest.com or call 877-527-6801

Package Label.Principal Display Panel

       

* Please review the disclaimer below.