YULAM DIE DA WAN HUA PAIN RELIEVING- menthol and camphor oil

YULAM DIE DA WAN HUA PAIN RELIEVING by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient
Menthol 3%
Camphor 4%

PURPOSE

Purpose
External analgesic
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

ADVERSE REACTIONS

Report any unexpected side effects from the use of this product to the FDA MedWatch Program.

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 2 years of age and older: Apply to affected area and rub gently. Do not use for more than 4 times a day.
■ children under 2 years of age: Do not use, consult a doctor.

STORAGE AND HANDLING

Other information
■ keep container tightly closed

■ store in a cool dry place away from sunlight

INACTIVE INGREDIENT

Inactive ingredients angelica dahurica (bai zhi) root, angelica pubescens (du huo) root, camellia oil, carthamus tinctorius (hong hua) flower bud, chimonanthus praecox (la mei hua) flower, chrysanthemum indicum (yeh chu hua) flower, curcuma involucrata (tu tian qi) root, cynanchum paniculatum (xu chang pu) root, drynaria fortunei (gu sui bu) root, gardenia jasminoides (zhi zi) fruit, ginger (jiang) root, gleditsia sinensis (da zao jiao) fruit, pueraria montana var. lobata (ge hua) flower top, ligusticum sinense (chuan xiong) root, lindera aggergata (wu yao) root, mentha canadensis (bo he) oil, notopterygium incisum (qiang huo) root, paeonia x suffruticosa (mu dan pi) root bark, rheum palmatum (da huang) root, saposhnikovia divaricata (fang feng) root, shellac, syzygium nervosum flower bud, tangerine (qing pi) unripe peel, tangerine (chen pi) peel, xanthium strumarium (cang er zi) fruit, zanthoxylum nitidum (liang mian zhen) root.

QUESTIONS

Questions or comments? (888) 221-3496 M-F 9 am to 5 pm
■ you may also report serious side effects to this phone number

PRINCIPAL DISPLAY PANEL

YULAM DIE DA WAN HUA PAIN RELIEVING OIL

NDC: 55614-740-01

EXTERNAL ANALGESIC

1.7 FL OZ (50 ML)

INGREDIENTS AND APPEARANCE

YULAM DIE DA WAN HUA PAIN RELIEVING 
menthol and camphor oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55614-740
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	3 g  in 100 mL
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ANGELICA DAHURICA ROOT (UNII: 1V63N2S972)
ANGELICA PUBESCENS ROOT (UNII: 0MF1EI01KJ)
CAMELLIA OIL (UNII: T1PE06G0VE)
CARTHAMUS TINCTORIUS FLOWER BUD (UNII: B86IS274O0)
CHIMONANTHUS PRAECOX WHOLE (UNII: 5Y143KS0YL)
CHRYSANTHEMUM INDICUM FLOWER (UNII: I6OER6U04L)
CURCUMA INVOLUCRATA ROOT (UNII: EW5ECF6XAX)
CYNANCHUM PANICULATUM ROOT (UNII: CZP7EPR012)
DRYNARIA FORTUNEI ROOT (UNII: 731W842X8Q)
GARDENIA JASMINOIDES FRUIT (UNII: 7CTH8MD549)
GINGER (UNII: C5529G5JPQ)
GLEDITSIA SINENSIS FRUIT (UNII: A6W0J6UO7Q)
PUERARIA MONTANA VAR. LOBATA FLOWERING TOP (UNII: HAM6R1WA7O)
LIGUSTICUM SINENSE ROOT (UNII: 32SLT970XO)
LINDERA AGGREGATA ROOT (UNII: 517Q7XRT2T)
MENTHA CANADENSIS WHOLE (UNII: J1BO4MHT2L)
NOTOPTERYGIUM INCISUM ROOT (UNII: 5Z2WW4J6RI)
PAEONIA X SUFFRUTICOSA ROOT BARK (UNII: BUG255FE7X)
RHEUM PALMATUM ROOT (UNII: G025DAL7CE)
SAPOSHNIKOVIA DIVARICATA ROOT (UNII: 8H84LFK2QD)
SHELLAC (UNII: 46N107B71O)
SYZYGIUM NERVOSUM FLOWER BUD (UNII: 7FA55IY5H8)
TANGERINE PEEL, UNRIPE (UNII: B077C3NLJV)
TANGERINE PEEL (UNII: JU3D414057)
XANTHIUM STRUMARIUM FRUIT (UNII: TN770YC17C)
ZANTHOXYLUM NITIDUM ROOT (UNII: L2CQZ81759)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55614-740-01	1 in 1 BOX	11/02/2022
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	11/02/2022

Labeler - MADISON ONE ACME INC (096196758)

Establishment
Name	Address	ID/FEI	Business Operations
GUANGZHOU BAIYUNSHAN JINGXIUTANG PHARMACEUTICAL CO., LTD.		654032218	manufacture(55614-740)