FDA.reportPublic FDA data

WHITE FLOWER ANALGESIC BALM FLORAL SCENTED

Manufacturer
HOE HIN PAK FAH YEOW MANUFACTORY LTD | HOE HIN PAK FAH YEOW MFY LTD
Effective date
2023-10-02
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-05-31 23:56:22

Label at a glance#

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

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 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 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

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

WARNINGS SECTION

Warnings

For external use only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

WHITE FLOWER ANALGESIC BALM FLORAL SCENTED  NDC-48256-0011-1  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 OilPSN9
1053359camphor 54 MG/ML / menthol 131 MG/ML / methyl salicylate 360 MG/ML Topical OilSCD9
1053359camphor 5.4 % / menthol 13.1 % / methyl salicylate 36 % Topical OilSY9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48256-0011-1WHITE FLOWER ANALGESIC BALM FLORAL SCENTED10 mL in 1 BOTTLE, GLASSOIL109
48256-0011-2WHITE FLOWER ANALGESIC BALM FLORAL SCENTED5 mL in 1 BOTTLE, GLASSOIL59

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48256-0011WHITE FLOWER ANALGESIC BALM FLORAL SCENTED (CAMPHOR, MENTHOL AND METHYL SALICYLATE) OIL [HOE HIN PAK FAH YEOW MANUFACTORY LTD]9Current NDC, Legacy NDC, 2 package rows20231003_4e9cb5aa-b0aa-4a5c-b561-cc38437758d8.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CAMPHOR (SYNTHETIC)ACTIVE INGREDIENT5TJD82A1ET4
MENTHOLACTIVE INGREDIENTL7T10EIP3A4
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022Y4
CAMPHOR (SYNTHETIC)ACTIVE MOIETY5TJD82A1ET4
MENTHOLACTIVE MOIETYL7T10EIP3A4
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ4
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI6624
LAVENDER OILINACTIVE INGREDIENTZBP1YXW0H84
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JH4

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
48256-001148256-0011-1, 48256-0011-2

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
EUCALYPTUS OIL2R04ONI662IACT
LAVENDER OILZBP1YXW0H8IACT
PEPPERMINT OILAV092KU4JHIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
MENTHOLL7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB

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 · 12 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PEPPERMINT OILPEPPERMINT OILAV092KU4JHSHAMPOO / TOPICAL0.2 %w/wExact identifier — unii+route
6 equally ranked IID candidates
EUCALYPTUS OILEUCALYPTUS OIL2R04ONI662SYRUP / ORALNAExact identifier — unii candidate
3 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHOINTMENT / TOPICAL0.2 %w/wExact identifier — unii+route
6 equally ranked IID candidates
LAVENDER OILLAVENDER OILZBP1YXW0H8GEL / TOPICAL0.1 %w/wExact identifier — unii+route
3 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHOINTMENT / TOPICAL0.2 %w/wExact identifier — unii+route
6 equally ranked IID candidates
EUCALYPTUS OILEUCALYPTUS OIL2R04ONI662SYRUP / ORALNAExact identifier — unii candidate
3 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHSHAMPOO / TOPICAL0.2 %w/wExact identifier — unii+route
6 equally ranked IID candidates
EUCALYPTUS OILEUCALYPTUS OIL2R04ONI662SYRUP / ORALNAExact identifier — unii candidate
3 equally ranked IID candidates
LAVENDER OILLAVENDER OILZBP1YXW0H8GEL / TOPICAL0.1 %w/wExact identifier — unii+route
3 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHSHAMPOO / TOPICAL0.2 %w/wExact identifier — unii+route
6 equally ranked IID candidates
LAVENDER OILLAVENDER OILZBP1YXW0H8GEL / TOPICAL0.1 %w/wExact identifier — unii+route
3 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHOINTMENT / TOPICAL0.2 %w/wExact identifier — unii+route
6 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
WHITE FLOWER ANALGESIC BALM FLORAL SCENTEDCAMPHOR, MENTHOL AND METHYL SALICYLATEHOE HIN PAK FAH YEOW MANUFACTORY LTD4e9cb5aa-b0aa-4a5c-b561-cc38437758d82023-10-02WarningsExact identifier
ndc (package): 48256-0011-1
ndc (package): 48256-0011-2
ndc (product): 48256-0011
ndc11 (package): 48256001102
ndc11 (package): 48256001101
spl id: 06c8a808-955c-6bd6-e063-6294a90a40fd
spl set id: 4e9cb5aa-b0aa-4a5c-b561-cc38437758d8

Reported adverse events (FAERS/openFDA)#

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