DIE DA WAN HUA PAIN RELIEVING- turpentine oil

DIE DA WAN HUA PAIN RELIEVING by

Drug Labeling and Warnings

DIE DA WAN HUA PAIN RELIEVING by is a Otc medication manufactured, distributed, or labeled by GUANGZHOU BAIYUNSHAN JINGXIUTANG PHARMACEUTICAL CO., LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient
Turpentine oil 6%

PURPOSE

Purpose
External analgesic

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

DO NOT USE

Do not use


• on wounds
• on irritated or damaged skin

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

DOSAGE & ADMINISTRATION

Directions

• Adults and children 2 years of age and older: Apply a few drops to affected area and rub gently. Do not use more than 3 to 4 times a day.
• Children under 2 years of age: Do not use, consult a doctor.

STORAGE AND HANDLING

Other information

• keep in a tightly closed container
• 
store in a cool dry place away from sunlight

INACTIVE INGREDIENT

Inactive ingredients
Camellia (Tsubaki oil) oil, cleistocalyx (Cleistocalyx operculatus) flower, dock (yang ti huang) root, dragon’s blood (xue jie) resin, drynaria (gu sui bu) rhizome, kudzu (ge hua) flower, lacca secretion (zi cao rong), lineate supplejack (Berchemia lineata) root, ragwort (Senecio palmatus), safflower (hong hua) flower, safflower (hong hua) oil, and winter sweet.

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

DIE DA WAN HUA PAIN RELIEVING OIL
External Analgesic
NDC: 61821-001-01
1.69 fl oz (50 mL)

INGREDIENTS AND APPEARANCE

DIE DA WAN HUA PAIN RELIEVING 
turpentine oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61821-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TURPENTINE (UNII: XJ6RUH0O4G) (TURPENTINE - UNII:XJ6RUH0O4G)	TURPENTINE	6 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CAMELLIA OIL (UNII: T1PE06G0VE)
SYZYGIUM NERVOSUM FLOWER BUD (UNII: 7FA55IY5H8)
RUMEX JAPONICUS ROOT (UNII: Q0N15YJ5EJ)
DRAGON'S BLOOD (UNII: M3YJ2C28IC)
DRYNARIA FORTUNEI WHOLE (UNII: TL552SP1Z7)
PUERARIA MONTANA VAR. LOBATA FLOWERING TOP (UNII: HAM6R1WA7O)
SHELLAC (UNII: 46N107B71O)
BERCHEMIA LINEATA ROOT (UNII: J146XBE5WH)
SAFFLOWER (UNII: 4VBL71TY4Y)
SAFFLOWER OIL (UNII: 65UEH262IS)
CHIMONANTHUS PRAECOX WHOLE (UNII: 5Y143KS0YL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61821-001-01	1 in 1 BOX	05/08/2003
1		50 mL in 1 BOTTLE, PLASTIC; 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	05/08/2003

Labeler - GUANGZHOU BAIYUNSHAN JINGXIUTANG PHARMACEUTICAL CO., LTD (654032218)

Establishment
Name	Address	ID/FEI	Business Operations
GUANGZHOU BAIYUNSHAN JINGXIUTANG PHARMACEUTICAL CO., LTD		654032218	manufacture(61821-001)