SHU JIN LU- camphor and menthol spray

SHU JIN LU by

Drug Labeling and Warnings

SHU JIN LU by is a Otc medication manufactured, distributed, or labeled by GUANGXI YULIN PHARMACEUTICAL CO LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients
Camphor 5.5%
Menthol 5.5% 

PURPOSE

Purposes
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
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: Spray on the affected area not more than3 to 4 times daily
children under 3 years of age: Do not use, consult a doctor
Refer to the above warnings; use otherwise than as directed may be dangerous.

STORAGE AND HANDLING

Other information
keep tightly closed
store at room temperature 15° to 30° C (59° to 86° F)

INACTIVE INGREDIENT

Inactive ingredients
bicolor artocarpus (Artocarpus styracifolius Pierre) root,
cinnamon twigs,
dimethyl sulfoxide,
futokadsura Kadsura heterocita (Roxb.) Craib stem,
fragrant angelica root,
gleditsia (Gleditsia sinensis Lam.) fruit,
hen’s eyes (Ardisia crenata Sims.) Root,
Japanese knotweed (Polygonum cuspidatum Siebold Zucc.) root,
methyl salicylate,
moghania (Moghania philippinensis Merr. Rolfe) root,
securidaca (Securidaca inappendiculata Hassk.) herb,
sheep’s ear (Inula cappa Buch.-Ham. ex D. Don) DC. herb,
St. Thomas bean Entada phaseoloides (L.) Merr. Stem,
swallowwort Cynanchum paniculatum (Bge.) Kitag. root and rhizome,
Vietnamese sophora (Sophora subprostrata Chun T.C. Chen) root,
wild pepper Piper wallichii (Miq.) Hand.-Mazz. twigs and leaves,
and zedoary rhizome.

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

SHU JIN LU  EXTERNAL ANALGESIC  NDC: 59321-031-01  2.0 fl oz (60mL)

INGREDIENTS AND APPEARANCE

SHU JIN LU 
camphor and menthol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59321-031
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	5.5 g  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CINNAMON (UNII: 5S29HWU6QB)
DIMETHYL SULFOXIDE (UNII: YOW8V9698H)
ANGELICA DAHURICA ROOT (UNII: 1V63N2S972)
GLEDITSIA SINENSIS FRUIT (UNII: A6W0J6UO7Q)
ARDISIA JAPONICA STEM (UNII: Q6CE3213C7)
POLYGONUM CUSPIDATUM ROOT (UNII: 7TRV45YZF7)
METHYL SALICYLATE (UNII: LAV5U5022Y)
ENTADA PHASEOLOIDES LEAF (UNII: W20C93AH7K)
CHELIDONIUM MAJUS (UNII: 7E889U5RNN)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
ZEDOARY (UNII: 123C43G128)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59321-031-01	60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	04/07/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/07/2011

Labeler - GUANGXI YULIN PHARMACEUTICAL CO LTD (653862581)

Establishment
Name	Address	ID/FEI	Business Operations
GUANGXI YULIN PHARMACEUTICAL CO LTD		653862581	manufacture(59321-031)