PHOENIX BALM- pain relief rub ointment

Phoenix Balm by

Drug Labeling and Warnings

Phoenix Balm by is a Otc medication manufactured, distributed, or labeled by Amazonian Naturals, Inc., Access Trading, SAC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Warnings    For external use only.

When using this product

• Avoid contact with eyes and mucous membranes.
  
• Do not apply to open wounds or damaged skin.
  
• Do not bandage or use heating pad.

Stop use and ask a doctor if

• Condition Worsens.
  
• Severe skin irritation occurs.
  
• Pain persists for more than seven days.
  
• Pain clears up and then recurs a few days later.

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

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

Directions

• Rub well on the affected area.  Repeat 2 or 3 times daily.
  
• For children 2 - 12 years, consult a doctor before use.

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PHOENIX BALM 
pain relief rub ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24438-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	50 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	50 mg  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y)	METHYL SALICYLATE	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)
CAT'S CLAW (UNII: 9060PRM18Q)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24438-001-02	1 in 1 BOX
1	NDC: 24438-001-01	19 g in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part348	12/01/2011

Labeler - Amazonian Naturals, Inc. (969562011)

Registrant - Amazonian Naturals, Inc. (969562011)

Establishment
Name	Address	ID/FEI	Business Operations
Amazonian Naturals, Inc.		969562011	relabel

Establishment
Name	Address	ID/FEI	Business Operations
Access Trading, SAC		953434516	manufacture