WHITE FLOWER ANALGESIC BALM- camphor, menthol, methyl salicylate oil

WHITE FLOWER ANALGESIC BALM by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Camphor 6%

Menthol 15%

Methyl salicylate 40%

PURPOSE

Purpose
External analgesic
External analgesic
External analgesic

DO NOT USE

Do not use

• on wounds
• on irritated or damaged skin
• on the face
• 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
  • 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 a few drops then gently rub into the affected area not more than 4 times daily.
• For younger children, consult your doctor.

STORAGE AND HANDLING

Other information

• keep container tightly closed
• store at 15° to 30°C (59° to 86°F)

INACTIVE INGREDIENT

Inactive ingredients Eucalyptus oil, lavender oil and peppermint oil.

QUESTIONS

Questions or comments? +1-626-823-9933 M-F 9am to 5pm

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

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

NDC: 48256-0002-1

0.676 fl oz (20 ml)

INGREDIENTS AND APPEARANCE

WHITE FLOWER ANALGESIC BALM 
camphor, menthol, methyl salicylate oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63047-0002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	6 g  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	14.5 g  in 100 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	40.02 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: 63047-0002-1	1 in 1 BOX	10/01/2018
1		20 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
2	NDC: 63047-0002-2	1 in 1 BOX	10/01/2018
2		10 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
3	NDC: 63047-0002-3	1 in 1 BOX	10/01/2018
3		5 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
4	NDC: 63047-0002-4	1 in 1 BOX	10/01/2018
4		2.5 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/11/2010

Labeler - MACAU-UNION PHARMACEUTICAL LTD (448605614)

Establishment
Name	Address	ID/FEI	Business Operations
MACAU-UNION PHARMACEUTICAL LTD		448605614	manufacture(63047-0002)

Establishment
Name	Address	ID/FEI	Business Operations
HOE HIN PAK FAH YEOW MANUFACTORY LTD		686212961	manufacture(63047-0002)