FDA.reportPublic FDA data

Ultra Balm

Manufacturer
Ling Nam Medicine Factory (H.K.) Ltd.
Effective date
2024-07-19
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 00:15:54

Label at a glance#

ProductUltra Balm
Active ingredientMenthol, Unspecified Form, Methyl Salicylate
Label structure11 sections

Indications and uses

for temporary relief of minor aches and pains of muscles and joints associated with simple backache arthritis strains bruises sprains

Dosage and administration

for adults and children 12 years of age and over, apply to affected area not more than 3 to 4 times daily for children 12 years or younger, consult a doctor before use not intended for children under two years of age

Storage and handling

Close cap tightly after use. Store in cool place.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active IngredientsPurpose
Menthol 14%Topical analgesic
Methyl Salicylate 23.2%Topical analgesic

Uses

INDICATIONS & USAGE SECTION

for temporary relief of minor aches and pains of muscles and joints associated with

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • If prone to allergic reaction from aspirin or salicylates

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes or mucous membranes
  • do not apply to wounds, damaged or irritated skin
  • do not bandage tightly or use with heating pad
  • do not use 1 hour prior to bathing or 30 minutes after bathing

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • skin irritation or redness develops
  • pain persists for more than 7 days
  • clear up and occur again within a few days

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask health professional before use.

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 Poison Control Center right away. Do not use otherwise than as directed.

Directions

DOSAGE & ADMINISTRATION SECTION

  • for adults and children 12 years of age and over, apply to affected area not more than 3 to 4 times daily
  • for children 12 years or younger, consult a doctor before use
  • not intended for children under two years of age

Other information

STORAGE AND HANDLING SECTION

Close cap tightly after use. Store in cool place.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Eucalyptus Oil, Lanolin, Paraffin, Petroleum Jelly and Thyme Oil

Questions or comments?

OTC - QUESTIONS SECTION

Please call 1-888-915-6789.

PRINCIPAL DISPLAY PANEL - 19.8 g Jar Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC.No : 57598-888-07

ULTRA BALM

LING NAM®
EXTERNAL ANALGESIC

COOLING
PAIN
RELIEF

Ling Nam Medicine Factory (H.K.) Limited
Tuen Mun, New Territories, Hong Kong, China
U.S.A. Sole Distributor: TCM Herbalway Inc.
Covina, CA 91724 U.S.A. www.tcmherbalway.com

Made in China Hong Kong
Net Wt.0.7 oz (19.8g)

PRINCIPAL DISPLAY PANEL - 19.8 g Jar Carton
PRINCIPAL DISPLAY PANEL - 19.8 g Jar Carton

PRINCIPAL DISPLAY PANEL - 65.1 g Jar Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC.No : 57598-888-23

ULTRA BALM

LING NAM®
EXTERNAL ANALGESIC

COOLING
PAIN
RELIEF

Ling Nam Medicine Factory (H.K.) Limited
Tuen Mun, New Territories, Hong Kong, China

Made in China
Net Wt.2.3 oz (65.1g)

PRINCIPAL DISPLAY PANEL - 65.1 g Jar Carton
PRINCIPAL DISPLAY PANEL - 65.1 g Jar Carton

PRINCIPAL DISPLAY PANEL - 65.1 g Jar Carton - NDC 57598-888-88

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC.No : 57598-888-88

ULTRA BALM

LING NAM®
EXTERNAL ANALGESIC

COOLING
PAIN
RELIEF

Ling Nam Medicine Factory (H.K.) Limited
Tuen Mun, New Territories, Hong Kong, China
U.S.A. Sole Distributor: TCM Herbalway Inc.
Covina, CA 91724 U.S.A. www.tcmherbalway.com

Made in China Hong Kong
Net Wt.2.3 oz (65.1g)

PRINCIPAL DISPLAY PANEL - 65.1 g Jar Carton - NDC 57598-888-88
PRINCIPAL DISPLAY PANEL - 65.1 g Jar Carton - NDC 57598-888-88

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1433205LING NAM ULTRA BALM 14 % / 23.2 % Topical OintmentPSN9
1433200menthol 14 % / methyl salicylate 23.2 % Topical OintmentPSN9
1433205menthol 0.14 MG/MG / methyl salicylate 0.232 MG/MG Topical Ointment [Ling Nam Ultra Balm]SBD9
1433200menthol 0.14 MG/MG / methyl salicylate 0.232 MG/MG Topical OintmentSCD9
1433205Ling Nam Ultra Balm (menthol 14 % / methyl salicylate 23.2 % ) Topical OintmentSY9
1433200menthol 14 % / methyl salicylate 23.2 % Topical OintmentSY9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57598-888-07Ultra Balm19.8 g in 1 JAROINTMENT19.89
57598-888-07Ultra Balm1 in 1 CARTONOINTMENT19
57598-888-23Ultra Balm65.1 g in 1 JAROINTMENT65.19
57598-888-23Ultra Balm1 in 1 CARTONOINTMENT19
57598-888-88Ultra Balm65.1 g in 1 JAROINTMENT65.19
57598-888-88Ultra Balm1 in 1 CARTONOINTMENT19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57598-888ULTRA BALM (MENTHOL AND METHYL SALICYLATE) OINTMENT [LING NAM MEDICINE FACTORY (H.K.) LTD.]9Current NDC, Legacy NDC, 6 package rows20240724_de997baf-aa04-474e-b912-3fc67e720d0b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MentholACTIVE INGREDIENTL7T10EIP3A1
Methyl SalicylateACTIVE INGREDIENTLAV5U5022Y1
MentholACTIVE MOIETYL7T10EIP3A1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ1
Eucalyptus OilINACTIVE INGREDIENT2R04ONI6621
LanolinINACTIVE INGREDIENT7EV65EAW6H1
ParaffinINACTIVE INGREDIENTI9O0E3H2ZE1
PetrolatumINACTIVE INGREDIENT4T6H12BN9U1
Thyme OilINACTIVE INGREDIENT2UK410MY6B1

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57598-88857598-888-07, 57598-888-23, 57598-888-88

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
Menthol, Unspecified FormL7T10EIP3AACTIB
Methyl SalicylateLAV5U5022YACTIB
Eucalyptus Oil2R04ONI662IACT
Lanolin7EV65EAW6HIACT
ParaffinI9O0E3H2ZEIACT
Petrolatum4T6H12BN9UIACT
Thyme Oil2UK410MY6BIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 16 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
LanolinLANOLIN7EV65EAW6HOINTMENT / TOPICAL10 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
Eucalyptus OilEUCALYPTUS OIL2R04ONI662SYRUP / ORALNAExact identifier — unii candidate
4 equally ranked IID candidates
LanolinLANOLIN7EV65EAW6HOINTMENT / TOPICAL10 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
ParaffinPARAFFINI9O0E3H2ZEOINTMENT / TOPICAL2860 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
ParaffinPARAFFINI9O0E3H2ZEOINTMENT / TOPICAL2860 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
ParaffinPARAFFINI9O0E3H2ZEOINTMENT / TOPICAL2860 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
Eucalyptus OilEUCALYPTUS OIL2R04ONI662SYRUP / ORALNAExact identifier — unii candidate
4 equally ranked IID candidates
Eucalyptus OilEUCALYPTUS OIL2R04ONI662SYRUP / ORALNAExact identifier — unii candidate
4 equally ranked IID candidates
LanolinLANOLIN7EV65EAW6HOINTMENT / TOPICAL10 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
Eucalyptus OilEUCALYPTUS OIL2R04ONI662SYRUP / ORALNAExact identifier — unii candidate
4 equally ranked IID candidates
LanolinLANOLIN7EV65EAW6HOINTMENT / TOPICAL10 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
ParaffinPARAFFINI9O0E3H2ZEOINTMENT / TOPICAL2860 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates

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
Ultra BalmMENTHOL AND METHYL SALICYLATELing Nam Medicine Factory (H.K.) Ltd.de997baf-aa04-474e-b912-3fc67e720d0b2024-07-19WarningsExact identifier
ndc (package): 57598-888-23
ndc (package): 57598-888-88
ndc (package): 57598-888-07
ndc (product): 57598-888
ndc11 (package): 57598088807
ndc11 (package): 57598088823
ndc11 (package): 57598088888
spl id: 46879b8b-9d05-4457-99ad-ddd77d90ceb7
spl set id: de997baf-aa04-474e-b912-3fc67e720d0b

Reported adverse events (FAERS/openFDA)#

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