WHITE FLOWER STRAIN RELIEF- camphor, menthol and methyl salicylate oil

WHITE FLOWER STRAIN RELIEF by

Drug Labeling and Warnings

WHITE FLOWER STRAIN RELIEF 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 10%

Menthol 15%

Methyl salicylate 48%

PURPOSE

Purpose

External Analgesic

INDICATIONS & USAGE

Uses

Tempoarily relieves minor aches and pains of muscles and joints due to:

• simple backache
• arthritis
• strains
• bruises
• sprains

WARNINGS

Warnings

For external use only

DO NOT USE

Do not use

• on wounds
• on irritated or damaged skin
• 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 persis for more than 7 days
• symptoms clear up and occur again within a few days
• excessive irritation 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 on the affected area not more than 3 to 4 times daily. After applying the product, a warm pad may be placed on the affected area for 10 minutes and then massage gently.
• children under 3 years of age: do not use, consult your physician
• refer to the above warnings; use otherwise than as directed may be dangerous

STORAGE AND HANDLING

Other information

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

INACTIVE INGREDIENT

Inactive ingredients

Beta carotene, Cassia oil, D C Green No. 6, D C Red No. 17, Eucalyptus oil, Fragrance, Lavender oil, Mineral oil.

QUESTIONS

Questions or comments?

(888) 221-3496 M-F 9 am to 5 pm

PRINCIPAL DISPLAY PANEL

WHITE FLOWER STRAIN RELIEF PAIN RELIEVING OIL NDC: 48256-0041-1 1.7 FL OZ (50 ML)

INGREDIENTS AND APPEARANCE

WHITE FLOWER STRAIN RELIEF 
camphor, menthol and methyl salicylate oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 48256-0041
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	10.2 g  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	15.3 g  in 100 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	49.1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
.BETA.-CAROTENE (UNII: 01YAE03M7J)
CHINESE CINNAMON OIL (UNII: A4WO0626T5)
D&C GREEN NO. 6 (UNII: 4QP5U84YF7)
D&C RED NO. 17 (UNII: ND733RX3JN)
EUCALYPTUS OIL (UNII: 2R04ONI662)
LAVENDER OIL (UNII: ZBP1YXW0H8)
MINERAL OIL (UNII: T5L8T28FGP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 48256-0041-1	50 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	03/07/2012
2	NDC: 48256-0041-2	25 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	03/07/2012
3	NDC: 48256-0041-3	3 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	03/07/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/07/2012

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

Establishment
Name	Address	ID/FEI	Business Operations
MACAU-UNION PHARMACEUTICAL LTD		448605614	repack(48256-0041)

Establishment
Name	Address	ID/FEI	Business Operations
HOE HIN PAK FAH YEOW MFY LTD		686212961	manufacture(48256-0041)