FDA.reportPublic FDA data

WHITE FLOWER ANALGESIC BALM

Manufacturer
JELMA PHILIPPINES INC
Effective date
2018-10-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:57:01

Label at a glance#

ProductWHITE FLOWER ANALGESIC BALM
Active ingredientCAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE
Label structure13 sections

Storage and handling

Other information keep container tightly closed store at 15º to 30ºC (59º to 86ºF)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients
Camphor 6%
Menthol 15%
Methyl salicylate 40%

OTC - PURPOSE SECTION

Purpose
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

OTC - DO NOT USE SECTION

Do not use

  • on wounds
  • on irritated or damaged skin
  • on the face
  • otherwise than as directed

WARNINGS SECTION

Warnings
For external use only

OTC - WHEN USING SECTION

When using this product

  • avoid contact with the eyes or mucous membranes
  • do not bandage tightly

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
  • 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

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 a few drops then gently rub into the affected area not more than 3 to 4 times daily.
  • Children under 3 years of age: Do not use, consult your doctor.
  • Refer to the above warnings; use otherwise than as directed may be dangerous.

STORAGE AND HANDLING SECTION

Other information

  • keep container tightly closed
  • store at 15º to 30ºC (59º to 86ºF)

INACTIVE INGREDIENT SECTION

Inactive ingredients
Eucalyptus oil, lavender oil and peppermint oil.

OTC - QUESTIONS SECTION

Questions or comments? (888)221-3496 M-F 9am to 5pm

  • you may also report serious side effects to this phone number

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

WHITE FLOWER ANALGESIC BALM  NDC-51681-0001-1  0.67 fl oz (20mL)IMAGE OF CARTON 20MLIMAGE OF CARTON 20ML

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1053407camphor 6 % / menthol 15 % / methyl salicylate 40 % Topical OilPSN3
1053407camphor 60 MG/ML / menthol 150 MG/ML / methyl salicylate 400 MG/ML Topical OilSCD3
1053407camphor 6 % / menthol 15 % / methyl salicylate 40 % Topical OilSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51681-0001-12021-01-29C16284748780-1ba0f9c33-4c5e-a910-e053-dadaa90a0b85DRUG FACTS
51681-0001-22021-01-29C16284748780-1ba0f9c33-4c5e-a910-e053-dadaa90a0b85DRUG FACTS
51681-0001-32021-01-29C16284748780-1ba0f9c33-4c5e-a910-e053-dadaa90a0b85DRUG FACTS
51681-0001-42021-01-29C16284748780-1ba0f9c33-4c5e-a910-e053-dadaa90a0b85DRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51681-0001-1WHITE FLOWER ANALGESIC BALM20 mL in 1 BOTTLE, GLASSOIL203
51681-0001-2WHITE FLOWER ANALGESIC BALM10 mL in 1 BOTTLE, GLASSOIL103
51681-0001-3WHITE FLOWER ANALGESIC BALM5 mL in 1 BOTTLE, GLASSOIL53
51681-0001-4WHITE FLOWER ANALGESIC BALM2.5 mL in 1 BOTTLE, GLASSOIL2.53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51681-0001WHITE FLOWER ANALGESIC BALM (CAMPHOR, MENTHOL, AND METHYL SALICYLATE) OIL [JELMA PHILIPPINES INC]3Legacy NDC, 4 package rows20181016_b047dade-a69e-40f5-b157-882bf2346796.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CAMPHOR (SYNTHETIC)ACTIVE INGREDIENT5TJD82A1ET2
MENTHOLACTIVE INGREDIENTL7T10EIP3A2
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022Y2
CAMPHOR (SYNTHETIC)ACTIVE MOIETY5TJD82A1ET2
MENTHOLACTIVE MOIETYL7T10EIP3A2
METHYL SALICYLATEACTIVE MOIETYLAV5U5022Y2
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI6622
LAVENDER OILINACTIVE INGREDIENTZBP1YXW0H82
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JH2

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51681-000151681-0001-1, 51681-0001-2, 51681-0001-4, 51681-0001-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
MENTHOLL7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB
EUCALYPTUS OIL2R04ONI662IACT
LAVENDER OILZBP1YXW0H8IACT
PEPPERMINT OILAV092KU4JHIACT

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 · 24 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PEPPERMINT OILPEPPERMINT OILAV092KU4JHSHAMPOO / TOPICAL0.2 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHTABLET / ORAL28 mgExact identifier — unii candidate
21 equally ranked IID candidates
LAVENDER OILLAVENDER OILZBP1YXW0H8GEL / TOPICAL0.1 %w/wExact identifier — unii candidate
2 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHGUM, CHEWING / ORAL526 mgExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHFILM, SOLUBLE / BUCCAL3 mgExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHSUSPENSION / ORAL100 mg/1mlExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHOINTMENT / TOPICAL0.2 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHSPRAY, METERED / SUBLINGUAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates
LAVENDER OILLAVENDER OILZBP1YXW0H8INHALANT / NASALNAExact identifier — unii candidate
2 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHSYRUP / ORAL120 mgExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHTABLET, ORALLY DISINTEGRATING / ORAL3 mgExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHFILM / BUCCAL12 mgExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHCAPSULE / ORAL60 mgExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHGUM, CHEWING / BUCCAL526 mgExact identifier — unii candidate
21 equally ranked IID candidates
EUCALYPTUS OILEUCALYPTUS OIL2R04ONI662SYRUP / ORALNAExact identifier — unii candidate
PEPPERMINT OILPEPPERMINT OILAV092KU4JHPOWDER, DENTIFRICE / DENTALNAExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHLOZENGE / ORAL12 mgExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHPOWDER / SUBLINGUAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHSOLUTION / DENTAL0.04 %v/vExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHPASTE, DENTIFRICE / DENTAL49.3 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHELIXIR / ORAL0.04 mg/1mlExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHTABLET / SUBLINGUAL0.15 mgExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHCONCENTRATE / ORAL0.05 mgExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHSOLUTION / ORAL53 mgExact identifier — unii candidate
21 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
869c24c5-dbbc-4511-a20e-43a1e293974db047dade-a69e-40f5-b157-882bf23467962018-10-15WarningsExact identifier
spl id: 869c24c5-dbbc-4511-a20e-43a1e293974d
spl set id: b047dade-a69e-40f5-b157-882bf2346796

Reported adverse events (FAERS/openFDA)#

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