PHOENIX BALM - pain relief rub ointment 
Amazonian Naturals, 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

Active Ingredients

Camphor 5%.................................... Topical Analgesic
Menthol 5% ..................................... Topical Analgesic
Methyl Salicylate 5%........................ Topical Analgesic

Purposes

Topical Analgesic

Uses

For temporary relief of minor aches and pains of muscles and joints associated with over-exertions, arthritis, strains and sprains.

Warnings    For external use only.

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding ask a health care professional before use.

Keep out of reach of children.  If swallowed get medical help or contact a Poisen Control Center immediately.

Directions

Other Information

This product may cause allergic reaction in some people.  Test on small area before use.

Inactive Ingredients

Pine needle oil, Cats Claw and Paraffin Petrolatum

Phoenix Balm Box FrontPhoenix Balm Box Back

PHOENIX BALM 
pain relief rub ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24438-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)50 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL50 mg  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y) METHYL SALICYLATE50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)  
CAT'S CLAW (UNII: 9060PRM18Q)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24438-001-021 in 1 BOX
1NDC:24438-001-0119 g in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34812/01/2011
Labeler - Amazonian Naturals, Inc. (969562011)
Registrant - Amazonian Naturals, Inc. (969562011)
Establishment
NameAddressID/FEIBusiness Operations
Amazonian Naturals, Inc.969562011relabel
Establishment
NameAddressID/FEIBusiness Operations
Access Trading, SAC953434516manufacture

Revised: 11/2011
Document Id: fab49a9f-9c0f-4a00-81cf-c9bbd5ef0826
Set id: 1ee482e2-155b-4f82-ab90-0457911806a8
Version: 1
Effective Time: 20111129
 
Amazonian Naturals, Inc.