NECK AND LUMBAR PAIN RELIEVING BALM- camphor, menthol, 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 11%
Menthol 16%
Methyl salicylate 30%

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
angelica sinensis root, biancaea sappan wood, citrus aurantium fruit, crassostrea gigas shell, cyathula officinalis root, dipsacus asper root, dragon's blood, eucommia ulmoides bark, frankincense, leonurus japonicus flowering top, ligusticum sinense subsp. chuanxiong root, myrrh, olive oil, panax notoginseng root, rubia cordifolia root, safflower, salvia miltiorrhiza root, senegalia catechu wood, spatholobus suberectus stem, taxillus chinensis top and white wax.

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

NECK & LUMBAR PAIN RELIEVING BALM

NDC 55614-660-01

EXTERNAL ANALGESIC

CAMPHOR, MENTHOL, METHYL SALICYLATE

2.82 OZ (80 G)
IMAGE OF BOX

NECK AND LUMBAR PAIN RELIEVING BALM 
camphor, menthol, and methyl salicylate oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55614-660
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)11 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL16 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE30 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ANGELICA SINENSIS ROOT (UNII: B66F4574UG)  
BIANCAEA SAPPAN WOOD (UNII: 086263LQDD)  
CITRUS AURANTIUM FRUIT (UNII: DQD16J2B5O)  
CRASSOSTREA GIGAS SHELL (UNII: 5I0R0U8ZL0)  
CYATHULA OFFICINALIS ROOT (UNII: BRM37UP34O)  
DIPSACUS ASPER ROOT (UNII: LB1GQP4253)  
DRAGON'S BLOOD (UNII: M3YJ2C28IC)  
EUCOMMIA ULMOIDES BARK (UNII: L878N1L0AR)  
FRANKINCENSE (UNII: R9XLF1R1WM)  
LEONURUS JAPONICUS FLOWERING TOP (UNII: V315CCZ08Z)  
LIGUSTICUM SINENSE SUBSP. CHUANXIONG ROOT (UNII: RR83T99U97)  
MYRRH (UNII: JC71GJ1F3L)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
PANAX NOTOGINSENG ROOT (UNII: GQX1C1175U)  
RUBIA CORDIFOLIA ROOT (UNII: 4V873H15CG)  
SAFFLOWER (UNII: 4VBL71TY4Y)  
SALVIA MILTIORRHIZA ROOT (UNII: 1693AM5SBN)  
SENEGALIA CATECHU WOOD (UNII: CHL342Y4LA)  
SPATHOLOBUS SUBERECTUS STEM (UNII: N51VZ363BA)  
TAXILLUS CHINENSIS TOP (UNII: QJ523LD71P)  
WHITE WAX (UNII: 7G1J5DA97F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55614-660-011 in 1 BOX05/15/2020
180 g 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(55614-660)

Revised: 5/2020
Document Id: 1d31a7dc-183d-4cf6-bf6d-858742109795
Set id: f67d9217-57b0-4b13-81a7-f6517d664f78
Version: 3
Effective Time: 20200518
 
MADISON ONE ACME INC