FDA.reportPublic FDA data

WHITE FLOWER ANALGESIC BALM FLORAL SCENTED

Manufacturer
JELMA PHILIPPINES INC
Effective date
2010-07-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:25:34

Label at a glance#

ProductWHITE FLOWER ANALGESIC BALM FLORAL SCENTED
Active ingredientCAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE
Label structure11 sections

Storage and handling

Other information keep tightly sealed store at or below 30º C (86º F), away from direct sunlight

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients
Camphor 5.4%
Menthol 13.1%
Methyl salicylate 36%

OTC - PURPOSE SECTION

Purpose

External analgesic


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

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 ag

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 one to two drops to the affected area not more than 3 to 4 times daily. Massage gently.
  • children under 3 years of age and pregnant women: do not use, consult a physician
  • refer to the above warnings; use otherwise than as directed may be dangerous

STORAGE AND HANDLING SECTION

Other information

  • keep tightly sealed
  • store at or below 30º C (86º F), away from direct sunlight

INACTIVE INGREDIENT SECTION

Inactive ingredients eucalyptus oil, fragrance, lavender oil, and peppermint oil.

OTC - QUESTIONS SECTION

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

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

WHITE FLOWER ANALGESIC BALM FLORAL SCENTED  NDC-51681-0011-1  0.338 FL OZ (10 ML)IMAGE OF CARTON 10MLIMAGE OF CARTON 10ML

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1053359camphor 5.4 % / menthol 13.1 % / methyl salicylate 36 % Topical OilPSN2
1053359camphor 54 MG/ML / menthol 131 MG/ML / methyl salicylate 360 MG/ML Topical OilSCD2
1053359camphor 5.4 % / menthol 13.1 % / methyl salicylate 36 % Topical OilSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51681-0011-12020-01-31C16284748780-19d75b9d0-5d3a-f424-e053-dadaa90a57ceDRUG FACTS
51681-0011-22020-01-31C16284748780-19d75b9d0-5d3a-f424-e053-dadaa90a57ceDRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51681-0011-1WHITE FLOWER ANALGESIC BALM FLORAL SCENTED10 mL in 1 BOTTLE, GLASSOIL102
51681-0011-2WHITE FLOWER ANALGESIC BALM FLORAL SCENTED5 mL in 1 BOTTLE, GLASSOIL52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51681-0011WHITE FLOWER ANALGESIC BALM FLORAL SCENTED (CAMPHOR, MENTHOL AND METHYL SALICYLATE) OIL [JELMA PHILIPPINES INC]2Legacy NDC, 2 package rows20100819_e323aa81-675c-4fe2-b643-9bd1fcebdaa4.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

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51681-001151681-0011-1, 51681-0011-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
MENTHOLL7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB

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
dea788c1-49a7-4f2a-8e70-792372de679de323aa81-675c-4fe2-b643-9bd1fcebdaa42010-07-30Exact identifier
spl id: dea788c1-49a7-4f2a-8e70-792372de679d
spl set id: e323aa81-675c-4fe2-b643-9bd1fcebdaa4

Reported adverse events (FAERS/openFDA)#

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