Drug Facts

Drug Facts

Drug Labeling and Warnings

Drug Details

k">

LUNG CHOY SHUNG PAIN RELIEF LIQUID- menthol and camphor liniment 
MADISON ONE ACME INC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Drug Facts

Active ingredient
Menthol 2.8%
Camphor 2.8%

Purpose
External analgesic
External analgesic

Uses
For the temporary relief of minor aches and pains of muscles and joints due to:
simple backache
arthritis
strains
bruises
sprains

Warnings
For external use only

Flammable: Keep away from fire or flame.

Do not use
on irritated or damaged skin
on wounds
if you are allergic to any ingredient in this product

Ask a doctor or pharmacist before use if you have
any concerns about using this product

When using this product
avoid contact with the eyes or mucous membranes
do not bandage tightly

do not apply heat to the area in the form of heating pads, hot water bottles, or lamps (doing so increases the risk of serious burns)

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

you feel actual pain or experience blistering or burning after application (it is normal to feel a warming or cooling sensation)

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

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions
adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.
children under 2 years of age: consult your physician

Other information
cap bottle tightly
store at room temperature, away from heat

Inactive ingredients
Alcohol, alisma plantago-aquatica subsp. orientale root , angelica dahurica root, angelica sinensis root, atractylodes lancea root, atractylodes macrocephala root, cinnamomum cassia twig, citrus aurantium fruit, cullen corylifolium fruit, cuscuta chinensis seed, cyperus rotundus tuber, dioscorea villosa tuber, erycibe obtusifolia stem, fennel seed, frankincense, gleditsia sinensis fruit, ligusticum sinense subsp. chuanxiong root, myrrh, notopterygium franchetii root, paeonia x suffruticosa root bark, panax notoginseng, root, polygonatum sibiricum root, polysorbate 80, prunus armeniaca seed, purified water, and tangerine peel.

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

Lung Choy Shung Pain Relief Liquid
External Analgesic
NDC: 55614-600-01
Menthol and Camphor
6.76 fl oz (200 mL)

Box2.jpg

LUNG CHOY SHUNG PAIN RELIEF LIQUID 
menthol and camphor liniment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 55614-600
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.8 g  in 100 mL
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)2.8 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
ALISMA PLANTAGO-AQUATICA SUBSP. ORIENTALE WHOLE (UNII: Z77940VG9A)  
ANGELICA DAHURICA ROOT (UNII: 1V63N2S972)  
ANGELICA SINENSIS ROOT (UNII: B66F4574UG)  
ATRACTYLODES LANCEA ROOT (UNII: CAZ6282J2O)  
ATRACTYLODES MACROCEPHALA ROOT (UNII: 08T3N29QJB)  
CINNAMOMUM CASSIA TWIG (UNII: 4UD6VQR2UP)  
CITRUS AURANTIUM FRUIT (UNII: DQD16J2B5O)  
CULLEN CORYLIFOLIUM FRUIT (UNII: 78AD6Z52S6)  
CUSCUTA CHINENSIS SEED (UNII: 77SZY178UD)  
CYPERUS ROTUNDUS TUBER (UNII: 4B51SRR959)  
DIOSCOREA VILLOSA TUBER (UNII: IWY3IWX2G8)  
ERYCIBE OBTUSIFOLIA STEM (UNII: V1G1S38CQI)  
FENNEL SEED (UNII: G3QC02NIE6)  
FRANKINCENSE (UNII: R9XLF1R1WM)  
GLEDITSIA SINENSIS FRUIT (UNII: A6W0J6UO7Q)  
LIGUSTICUM SINENSE SUBSP. CHUANXIONG ROOT (UNII: RR83T99U97)  
MYRRH (UNII: JC71GJ1F3L)  
NOTOPTERYGIUM FRANCHETII ROOT (UNII: KRT28P6ITK)  
PAEONIA X SUFFRUTICOSA ROOT BARK (UNII: BUG255FE7X)  
PANAX NOTOGINSENG ROOT (UNII: GQX1C1175U)  
POLYGONATUM SIBIRICUM ROOT (UNII: O6N69G5Q18)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PRUNUS ARMENIACA SEED (UNII: 75356789IW)  
WATER (UNII: 059QF0KO0R)  
TANGERINE PEEL (UNII: JU3D414057)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 55614-600-01200 mL in 1 BOTTLE; Type 0: Not a Combination Product11/25/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/25/2019
Labeler - MADISON ONE ACME INC (096196758)
Establishment
NameAddressID/FEIBusiness Operations
Zhejiang Dingtai Pharmaceutical Co., Ltd420598724manufacture(55614-600)

Revised: 12/2019
 
MADISON ONE ACME INC


© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.