Herbal Balm

Manufacturer
Big 5 Nutrition LLC | Taiwan Shuenn-Ann Biotechnology Pharmaceutical Co., Ltd.
Effective date
2023-11-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:02:32

Label at a glance#

ProductHerbal Balm
Active ingredientMENTHOL, METHYL SALICYLATE, CAMPHOR (SYNTHETIC)
Label structure9 sections

Indications and uses

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

Dosage and administration

Apply to the affected area. Rub well on affected area. Repeat 2 times daily.  Children under 2 years of age: Do not use or consult a doctor.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Methyl Salicylate 20.7%

Menthol 15.6%

Camphor 3.1%

Purpose

OTC - PURPOSE SECTION

External analgesic

Uses

INDICATIONS & USAGE SECTION

For temporary relief of minor aches and pains of muscles and joints due to:

  • arthritis
  • strains
  • bruises
  • sprains
  • simple backache

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use

  • on wounds

  • irritated or damaged skin

  • sensative skin

  • with a heating pad

  • if pregnant

  • with, or as the same time as, other external analgesic products

  • if allergic to aspirin or salicylates

  • if allergic to any ingredients of this prodcut

OTC - WHEN USING SECTION

When using this product

  • avoid contact with eyes
  • do not bandage tightly
  • do not apply to wounds or damaged skin
  • do not use 1 hour before or after bathing

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
  • redness is present
  • side effects occur

SPL UNCLASSIFIED SECTION

If pregnant, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of childrento avoid accidental poisoning

In case of overdose, get medical help or contact a Poison Control Center right away.

Do not use otherwise than as directed.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply to the affected area. Rub well on affected area.
  • Repeat 2 times daily.
  •  Children under 2 years of age: Do not use or consult a doctor.

Other Information

SPL UNCLASSIFIED SECTION

  • Store at room temperature, 20 to 25°C (68 to 77°F)

Other Ingredients

INACTIVE INGREDIENT SECTION

Eucalyptus Oil, Lavender Oil, Vaseline, White beeswax.

Questions or Comments?

OTC - QUESTIONS SECTION

Tel: 714-531-2020

Web: tnduocthao.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82198-0007-1Herbal Balm50 g in 1 JARCREAM502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82198-0007HERBAL BALM (METHYL SALICYLATE, MENTHOL AND) CREAM [BIG 5 NUTRITION LLC]2Current NDC, Legacy NDC, 1 package rows20231122_09b3b86d-3434-428b-b0a8-e8dfd7c0b52a.zip

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
82198-000782198-0007-1

Ingredients#

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

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

Source Document#

Source XML

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
Herbal BalmMETHYL SALICYLATE, MENTHOL ANDBig 5 Nutrition LLC09b3b86d-3434-428b-b0a8-e8dfd7c0b52a2023-11-20WarningsExact identifier
ndc (package): 82198-0007-1
ndc (product): 82198-0007
ndc11 (package): 82198000701
spl id: 0aa37145-cd8b-beb7-e063-6394a90afa97
spl set id: 09b3b86d-3434-428b-b0a8-e8dfd7c0b52a

Reported adverse events (FAERS/openFDA)#

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