SHENNONG ANALGESIC PLASTER- camphor, menthol, methyl salicylate plaster 
Guangdong Zhanjiang Jimin Pharmaceutical Co. Ltd

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.

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Guangdong Zhanjiang Jimin Pharmaceutical Co, Ltd

Active Ingredients

Camphor    4.28%

Menthol      2.84%

Methyl Salicylate  1.4%

Purpose

Camphor                  External Analgesic

Menthol                    External Analgesic

Methyl Salicylate       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.

Do not use on pregnant woman.

Do not use

on wounds, irritated or damaged skin, otherwise than as directed.

When using this product

Avoid contact with the eyes or mucous membranes.

Do not bandage tightly.

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 and if redness is present.

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.

Directions

Clean and dry the affected area. Remove the paper backing from the plaster. Apply the plaster to the affected area. Change plasters as needed, but do not apply more than 3 to 4 times daily.

Children under 12 years of age: contact a doctor.

Other Information

Keep tightly closed.

Store at room temperature, 20 to 25 °C (68-77 °F)

Inactive Ingredients

PANAX PSEUDOGINSENG ROOT, ANGELICA DAHURICA ROOT, CIBOTIUM BAROMETZ ROOT, NOTOPTERYGIUM INCISUM ROOT, SAPOSHNIKOVIA DIVARICATA ROOT, ACTAEA CIMICIFUGA ROOT, SAFFLOWER, LIGUSTICUM WALLICHII ROOT, ANGELICA SINENSIS ROOT, MYRRH, PARIS POLYPHYLLA WHOLE, FRANKINCENSE, BASIL OIL, ATROPA BELLADONNA, NATURAL LATEX RUBBER, ROSIN, ZINC OXIDE, PETROLATUM, LANOLIN

Drug Facts

image description

SHENNONG ANALGESIC PLASTER 
camphor, menthol, methyl salicylate plaster
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68048-922
Route of AdministrationTRANSDERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)4.28 mg  in 100 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.84 mg  in 100 mg
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE1.4 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
PANAX PSEUDOGINSENG ROOT (UNII: NMK0ZS613U)  
ANGELICA DAHURICA ROOT (UNII: 1V63N2S972)  
CIBOTIUM BAROMETZ ROOT (UNII: 2YP9JGT10R)  
NOTOPTERYGIUM INCISUM ROOT (UNII: 5Z2WW4J6RI)  
SAPOSHNIKOVIA DIVARICATA ROOT (UNII: 8H84LFK2QD)  
ACTAEA CIMICIFUGA ROOT (UNII: 65J267BAZT)  
SAFFLOWER (UNII: 4VBL71TY4Y)  
LIGUSTICUM WALLICHII ROOT (UNII: R81AD159QS)  
ANGELICA SINENSIS ROOT (UNII: B66F4574UG)  
MYRRH (UNII: JC71GJ1F3L)  
PARIS POLYPHYLLA WHOLE (UNII: 1E5W175DRX)  
FRANKINCENSE (UNII: R9XLF1R1WM)  
BASIL OIL (UNII: Z129UMU8LE)  
ATROPA BELLADONNA (UNII: WQZ3G9PF0H)  
NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)  
ROSIN (UNII: 88S87KL877)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
PETROLATUM (UNII: 4T6H12BN9U)  
LANOLIN (UNII: 7EV65EAW6H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68048-922-088 in 1 BOX
12.5 mg in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/01/2016
Labeler - Guangdong Zhanjiang Jimin Pharmaceutical Co. Ltd (654041649)
Registrant - Guangdong Zhanjiang Jimin Pharmaceutical Co, Ltd (654041649)
Establishment
NameAddressID/FEIBusiness Operations
Guangdong Zhangjiang Jimin Pharmaceutical Co. Ltd654041649manufacture(68048-922)

Revised: 3/2016
Document Id: 6a4b574a-93bb-425c-87a3-8638c72f7bcb
Set id: f635bfa5-6b55-48a4-9de8-c569df60a294
Version: 3189
Effective Time: 20160316
 
Guangdong Zhanjiang Jimin Pharmaceutical Co. Ltd