NECK and LUMBAR PAIN RELIEVING BALM

Manufacturer
MADISON ONE ACME INC | Zhejiang Dingtai Pharmaceutical Co., Ltd
Effective date
2020-05-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:26:30

Label at a glance#

ProductNECK and LUMBAR PAIN RELIEVING BALM
Active ingredientCAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE
Label structure15 sections

Storage and handling

Other information ■ keep container tightly closed
 ■ store protected from light at 15 to 30 C (59 to 86 F)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient
Camphor 11%
Menthol 16%
Methyl salicylate 30%

OTC - PURPOSE SECTION

Purpose
External analgesic
External analgesic
External analgesic

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Warnings
For external use only

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - WHEN USING SECTION

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)

OTC - STOP USE SECTION

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

ADVERSE REACTIONS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

Other information
■ keep container tightly closed

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

INACTIVE INGREDIENT SECTION

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.

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NECK & LUMBAR PAIN RELIEVING BALM

NDC 55614-660-01

EXTERNAL ANALGESIC

CAMPHOR, MENTHOL, METHYL SALICYLATE

2.82 OZ (80 G)
IMAGE OF BOXIMAGE OF BOX

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130049987015676GTIN-13: 0049987015676
EAN-13: 0049987015676
GTIN-12: 049987015676
UPC-A: 049987015676
GTIN storage (14 digits): 00049987015676
Box1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55614-660-012022-01-28C16284748780-1d6a99b39-e125-a426-e053-dadaa90af4c2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55614-660-01NECK and LUMBAR PAIN RELIEVING BALM1 in 1 BOXOIL13
55614-660-01NECK and LUMBAR PAIN RELIEVING BALM80 g in 1 BOTTLE, GLASSOIL803

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55614-660NECK AND LUMBAR PAIN RELIEVING BALM (CAMPHOR, MENTHOL, AND METHYL SALICYLATE) OIL [MADISON ONE ACME INC]3Legacy NDC, 2 package rows20200901_f67d9217-57b0-4b13-81a7-f6517d664f78.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55614-66055614-660-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
1d31a7dc-183d-4cf6-bf6d-858742109795f67d9217-57b0-4b13-81a7-f6517d664f782020-05-18Warnings, Adverse reactionsExact identifier
spl id: 1d31a7dc-183d-4cf6-bf6d-858742109795
spl set id: f67d9217-57b0-4b13-81a7-f6517d664f78

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.