FDA.reportPublic FDA data

Balm Stick

Manufacturer
Indo Abadi Sari Makmur, PT
Effective date
2021-12-27
Label type
HUMAN OTC DRUG LABEL
Version
32799
Source
full-release
Hydrated at
2026-05-31 23:45:57

Label at a glance#

ProductBalm Stick
Active ingredientMETHYL SALICYLATE, MENTHOL, CAMPHOR (SYNTHETIC)
Label structure10 sections

Indications and uses

Relieves muscle pains, lumbago, insect bites, itching

Dosage and administration

Apply to the affected area as needed.

Storage and handling

Keep container tightly closed. Store at 16 to 30 degrees centigrade (69 to 86 Farenheit).

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Methyl Salicylate  7%

Menthol  13%

Camphor  12%

Purpose

OTC - PURPOSE SECTION

Methyl Salicylate     External Analgesic

Menthol         External Analgesic

Camphor    External Analgesic

Uses

INDICATIONS & USAGE SECTION

Relieves muscle pains, lumbago, insect bites, itching

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Apply to the affected area as needed.

Warnings

WARNINGS SECTION

External Use Only. Do not use for children below 2 years of age. Avoid direct application into the nostrils.

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Warnings

OTC - STOP USE SECTION

Stop use and ask 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, vomitting, abdominal discomfort, diarrhea, or skin rash occurs

When using for pain of arthritis: pain persits for more than 10 days, redness is present, in conditions affecting children 12 years of age.

Other Information

STORAGE AND HANDLING SECTION

Keep container tightly closed. Store at 16 to 30 degrees centigrade (69 to 86 Farenheit).

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Eucalyptus Oil, Capsicum, Peppermint Oil, Borneol

Drug Facts

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Drug FactsDrug Facts

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1806690camphor 12 % / menthol 13 % / methyl salicylate 7 % Topical OintmentPSN32799
1806690camphor 0.12 MG/MG / menthol 0.13 MG/MG / methyl salicylate 0.07 MG/MG Topical OintmentSCD32799
1806690camphor 12 % / menthol 13 % / methyl salicylate 7 % Topical OintmentSY32799
1806690camphor 12 % / menthol 13 % / methyl salicylate 7 % Topical StickSY32799

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70815-001-202023-01-30C16284748780-1f386c649-a57a-0266-e053-dadaa90a7c1aIndo Abadi Sari Makmur, PT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70815-001-20Balm Stick20 g in 1 TUBESTICK2032799
70815-001-20Balm Stick1 in 1 CARTONSTICK132799

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70815-001BALM STICK (CAMPHOR, MENTHOL, METHYL SALICYLATE) STICK [INDO ABADI SARI MAKMUR, PT]32799Legacy NDC, 2 package rows20211228_3756ef07-6317-4c0e-b036-080e964128fa.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
70815-00170815-001-20

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
METHYL SALICYLATELAV5U5022YACTIB
MENTHOLL7T10EIP3AACTIB
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
EUCALYPTUS OIL2R04ONI662IACT
CAPSICUM00UK7646FGIACT
PEPPERMINT OILAV092KU4JHIACT
BORNEOLM89NIB437XIACT

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
3f87b876-10ea-4475-a894-6010ed3fd22f3756ef07-6317-4c0e-b036-080e964128fa2021-12-27WarningsExact identifier
spl id: 3f87b876-10ea-4475-a894-6010ed3fd22f
spl set id: 3756ef07-6317-4c0e-b036-080e964128fa

Reported adverse events (FAERS/openFDA)#

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