FDA.reportPublic FDA data

IMADA FOUR SEASONS SAFE ANALGESIC BALM

Manufacturer
LUEN WAH HK MEDICINE LTD
Effective date
2019-11-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:57:57

Label at a glance#

ProductIMADA FOUR SEASONS SAFE ANALGESIC BALM
Active ingredientMENTHOL
Label structure13 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

​Drug Facts

Active Ingredients

Menthol 16%

OTC - PURPOSE SECTION

​Purpose

​External Analgesic

INDICATIONS & USAGE SECTION

​Uses

​Temporarily relieves minor aches, muscles and joint pains due to:

  • simple backache
  • arthritis
  • strains
  • sprains
  • bruises
  • neck
  • shoulder
  • stiff and sore muscles

WARNINGS SECTION

​Warnings

  • ​external use only
  • use only as directed

OTC - DO NOT USE SECTION

​Do not use

  • ​on opened wounds
  • on damaged skin

OTC - WHEN USING SECTION

​When using this product

  • ​avoid contact with the eyes
  • do not bandage tighly

OTC - STOP USE SECTION

​Stop use and ask a doctor if

  • ​a rash or irritation develops
  • condition worsens
  • symptoms persist for more than 7 days or clears up and occur again within a few days

OTC - PREGNANCY OR BREAST FEEDING SECTION

​If pregnant or breast-feeding,​ ask a health professional before use

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 12 years and older, apply to affected area, and massage gently not more than 3-4 times daily
  • children under 12 years of age, consult a doctor before using

OTHER SAFETY INFORMATION

​Other information

  • ​store at room temperature
  • close tightly after used

INACTIVE INGREDIENT SECTION

​ ​Inactive ingredients

​peppermint oil, cassia oil, clove oil, cinnamon leaf oil, licorice

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Imada_FSS_Oil_25mL2mLImada_FSS_Oil_25mL2mL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3A1
MENTHOLACTIVE MOIETYL7T10EIP3A1
CINNAMON LEAF OILINACTIVE INGREDIENTS92U8SQ71V1
CLOVE OILINACTIVE INGREDIENT578389D6D01
LICORICEINACTIVE INGREDIENT61ZBX548831
PADANG CASSIA OILINACTIVE INGREDIENT0E15252LIW1
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JH1

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63041-11063041-110-01, 63041-110-02

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
MENTHOLL7T10EIP3AACTIB
PEPPERMINT OILAV092KU4JHIACT
PADANG CASSIA OIL0E15252LIWIACT
CLOVE OIL578389D6D0IACT
CINNAMON LEAF OILS92U8SQ71VIACT
LICORICE61ZBX54883IACT

Source Document#

Source XML · Source PDF

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
CLOVE OILCLOVE OIL578389D6D0ELIXIR / ORAL0.42 mg/5mlExact identifier — unii candidate
3 equally ranked IID candidates
CLOVE OILCLOVE OIL578389D6D0PASTE, DENTIFRICE / DENTAL2.4 %w/wExact identifier — unii candidate
3 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHSPRAY, METERED / SUBLINGUAL1 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 OILAV092KU4JHPOWDER, DENTIFRICE / DENTALNAExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHGUM, CHEWING / ORAL526 mgExact 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 OILAV092KU4JHSOLUTION / DENTAL0.04 %v/vExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHTABLET / SUBLINGUAL0.15 mgExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHFILM / BUCCAL12 mgExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHSYRUP / ORAL120 mgExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHSHAMPOO / TOPICAL0.2 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHSOLUTION / ORAL53 mgExact identifier — unii candidate
21 equally ranked IID candidates
CLOVE OILCLOVE OIL578389D6D0SUSPENSION / ORAL0.1 mg/5mlExact identifier — unii candidate
3 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHGUM, CHEWING / BUCCAL526 mgExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHTABLET / ORAL28 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 OILAV092KU4JHELIXIR / ORAL0.04 mg/1mlExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHCAPSULE / ORAL60 mgExact 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 OILAV092KU4JHTABLET, ORALLY DISINTEGRATING / ORAL3 mgExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHPOWDER / SUBLINGUAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHLOZENGE / ORAL12 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
21050594-cbb0-47d6-9d13-a2ddc2ae49894b71aed7-6a4a-4a40-a04b-21b5cd4bdfbc2019-11-21WarningsExact identifier
spl id: 21050594-cbb0-47d6-9d13-a2ddc2ae4989
spl set id: 4b71aed7-6a4a-4a40-a04b-21b5cd4bdfbc

Reported adverse events (FAERS/openFDA)#

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