EARTHS BEST COLD RELIEF VAPOR - camphor, menthol, eucalyptus globulus leaf oil ointment 
The Hain Celestial Group, Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Drug Facts

Camphor                                   5.3%

Menthol                                     2.8%

Eucalyptus Globulus Leaf Oil      1.3%

Natural Skin Protectant

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.

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

See important warnings under "When using this product". Adults and children 2 years old and older:

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

* Certified Organic Ingredients

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

image of jar label        image of carton label

EARTHS BEST COLD RELIEF VAPOR 
camphor, menthol, eucalyptus globulus leaf oil ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-0758
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)5.3 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.8 g  in 100 g
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL1.3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SUNFLOWER OIL (UNII: 3W1JG795YI)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61995-0758-21 in 1 CARTON
180 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/13/2011
Labeler - The Hain Celestial Group, Inc (858894996)
Establishment
NameAddressID/FEIBusiness Operations
The Hain Celestial Group, Inc858894996manufacture

Revised: 5/2012
Document Id: de6c79e0-dfe2-4e13-9edf-0b0c3703a7f4
Set id: 8f8beee0-8a27-4b31-90b9-9d3066dc67fe
Version: 1
Effective Time: 20120523
 
The Hain Celestial Group, Inc