HONG HOA PAIN RELIEVING- camphor, capsaicin, and 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 ingredient
Camphor 10%
Capsaicin 0.025% (from capsicum oleoresin)
Methyl salicylate 60%

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 irritated or damaged skin
■ on wounds

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  cinnamon leaf oil, cinnamon oil, citronella oil, dragon’s blood, and light mineral oil.

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

HONG HOA PAIN RELIEVING OIL

NDC 55614-640-02

EXTERNAL ANALGESIC

1.69 FL OZ (50 ML)
Image of box

HONG HOA PAIN RELIEVING 
camphor, capsaicin, and methyl salicylate oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55614-640
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
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.025 g  in 100 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE60 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CINNAMON LEAF OIL (UNII: S92U8SQ71V)  
CINNAMON OIL (UNII: E5GY4I6YCZ)  
CITRONELLA OIL (UNII: QYO8Q067D0)  
DRAGON'S BLOOD (UNII: M3YJ2C28IC)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55614-640-021 in 1 BOX05/15/2020
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 finalpart34805/15/2020
Labeler - MADISON ONE ACME INC (096196758)
Establishment
NameAddressID/FEIBusiness Operations
Zhejiang Dingtai Pharmaceutical Co., Ltd420598724manufacture(55614-640)

Revised: 5/2020
Document Id: 429afaf3-a887-4406-92c9-a904b3edfd68
Set id: c29839ce-1218-4cc4-bf5d-5ec7b388da45
Version: 1
Effective Time: 20200515
 
MADISON ONE ACME INC