SHU JIN HUO LUO PAIN RELIEVING- camphor, menthol, methyl salicylate oil 
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.

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Drug Facts

Active ingredients
Camphor 10%
Menthol 16%
Methyl salicylate 50%

Purpose
External analgesic
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

Do not use
■ on wounds
■ on irritated or damaged skin

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

When using this product
■ do not use otherwise than as directed

■ 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 to avoid accidental poisoning. If swallowed, get medical help or contact a Poison Control Center right away.

Directions
■ adults and children 3 years of age and older: apply several drops and rub Into the affected area not more than 3 to 4 times daily

■ children under 3 years of age: consult your physician

Other information
■ keep container tightly closed

■ store protected from light at 15 to 30 C (59 to 86 F)

Inactive ingredients
Angelica biserrata root, angelica sinensis root, arisaema erubescens root, chaenomeles lagenaria fruit, cinnamomum cassia twig, clematis chinensis root, cyathula officinalis root, dragon’s blood, eleutherococcus nodiflorus root bark, illicium difengpi bark, lavender oil, light mineral oil, ligusticum sinense subsp. chuanxiong root, narcissus jonquilla flower oil, notopterygium franchetii root, and sigesbeckia orientalis flowering top.

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

SHU JIN HUO LUO PAIN RELIEVING OIL

NDC 55614-670-01

EXTERNAL ANALGESIC

1.69 FL OZ (50 ML)
IMAGE OF BOX

SHU JIN HUO LUO PAIN RELIEVING 
camphor, menthol, methyl salicylate oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55614-670
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)10 g  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL16 g  in 100 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE50 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ANGELICA BISERRATA ROOT (UNII: OJ90180B22)  
ANGELICA SINENSIS ROOT (UNII: B66F4574UG)  
ARISAEMA ERUBESCENS ROOT (UNII: 3E8P1PU8SY)  
CHAENOMELES LAGENARIA FRUIT (UNII: XBC17A15MU)  
CINNAMOMUM CASSIA TWIG (UNII: 4UD6VQR2UP)  
CLEMATIS CHINENSIS ROOT (UNII: 8Z18N528CU)  
CYATHULA OFFICINALIS ROOT (UNII: BRM37UP34O)  
DRAGON'S BLOOD (UNII: M3YJ2C28IC)  
ELEUTHEROCOCCUS NODIFLORUS ROOT BARK (UNII: W7PRK433YB)  
ILLICIUM DIFENGPI BARK (UNII: JRF2FQL2SB)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
LIGUSTICUM SINENSE SUBSP. CHUANXIONG ROOT (UNII: RR83T99U97)  
NARCISSUS JONQUILLA FLOWER OIL (UNII: QJD826L75Z)  
NOTOPTERYGIUM FRANCHETII ROOT (UNII: KRT28P6ITK)  
SIGESBECKIA ORIENTALIS FLOWERING TOP (UNII: 6UL878YAR7)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55614-670-011 in 1 BOX03/23/2021
150 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/23/2021
Labeler - MADISON ONE ACME INC (096196758)
Establishment
NameAddressID/FEIBusiness Operations
Zhejiang Dingtai Pharmaceutical Co., Ltd420598724manufacture(55614-670)

Revised: 4/2021
Document Id: feed8e80-3d51-43a7-b449-83415a51c4d0
Set id: ccb6740d-3399-4a2b-ae65-15ca557ba83b
Version: 3
Effective Time: 20210401
 
MADISON ONE ACME INC