WHITE FLOWER ANALGESIC BALM FLORAL SCENTED- camphor, menthol and methyl salicylate oil

WHITE FLOWER ANALGESIC BALM FLORAL SCENTED by

Drug Labeling and Warnings

WHITE FLOWER ANALGESIC BALM FLORAL SCENTED by is a Otc medication manufactured, distributed, or labeled by HOE HIN PAK FAH YEOW MANUFACTORY LTD, HOE HIN PAK FAH YEOW MFY LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Camphor 5.4%

Menthol 13.1%

Methyl salicylate 36%

PURPOSE

Purpose

External analgesic

DO NOT USE

Do not use

• on irritated or damaged skin
• on wounds
• otherwise than as directed
  

WHEN USING

When using this product

• avoid contact with the eyes or mucous membranes
• do not bandage tightly
  

STOP USE

Stop use and ask a doctor if

• condition worsens
• symptoms persist for more than 7 days
• symptoms clear up and occur again within a few days
• excessive irritation of the skin develops
• nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs
• when using for pain of arthritis:
• • pain persists for more than 10 days
  • redness is present
  • in conditions affecting children under 12 years of age

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children to avoid accidental poisoning.

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

• adults and children 3 years of age and older: apply one to two drops to the affected area not more than 3 to 4 times daily. Massage gently.
• children under 3 years of age and pregnant women: do not use, consult a physician
• refer to the above warnings; use otherwise than as directed may be dangerous
  

STORAGE AND HANDLING

Other information

• keep tightly sealed
• store at or below 30º C (86º F), away from direct sunlight
  

INACTIVE INGREDIENT

Inactive ingredients eucalyptus oil, fragrance, lavender oil, and peppermint oil.

QUESTIONS

Questions or comments? (888) 221-3496 M-F 9 am to 5 pm

• you may also use this phone number to report serious side effects
  

INDICATIONS & USAGE

Uses For the temporary relief of minor aches and pains of muscles and joints due to: 

• simple backache
  
• arthritis
  
• strains
  
• bruises
  
• sprains

WARNINGS

Warnings

For external use only

PRINCIPAL DISPLAY PANEL

WHITE FLOWER ANALGESIC BALM FLORAL SCENTED  NDC-48256-0011-1  0.338 fl oz (10 mL)

INGREDIENTS AND APPEARANCE

WHITE FLOWER ANALGESIC BALM FLORAL SCENTED 
camphor, menthol and methyl salicylate oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 48256-0011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	5.4 g  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	13 g  in 100 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	35.8 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
EUCALYPTUS OIL (UNII: 2R04ONI662)
LAVENDER OIL (UNII: ZBP1YXW0H8)
PEPPERMINT OIL (UNII: AV092KU4JH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 48256-0011-1	10 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	07/30/2010
2	NDC: 48256-0011-2	5 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	07/30/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	07/30/2010

Labeler - HOE HIN PAK FAH YEOW MANUFACTORY LTD (686359001)

Establishment
Name	Address	ID/FEI	Business Operations
MACAU-UNION PHARMACEUTICAL LTD		448605614	repack(48256-0011)

Establishment
Name	Address	ID/FEI	Business Operations
HOE HIN PAK FAH YEOW MFY LTD		686212961	manufacture(48256-0011)