Silmanix Pain Relieiving Cream

Manufacturer
Home Aide Diagnostics, Inc. | Zhejiang Bangli Medical Products Cl. Ltd | Zhejiang Bangli Medical Products Co. Ltd
Effective date
2015-07-07
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 20:20:57

Label at a glance#

ProductSimanix
Active ingredientCAPSAICIN, MENTHOL, HISTAMINE DIHYDROCHLORIDE
Label structure10 sections

Label contents#

Full prescribing information#

INFORMATION FOR PATIENTS SECTION

PURPOSE: Topical analgesic

INFORMATION FOR PATIENTS SECTION

ACTIVE INGREDIENTS
Capsaicin 0.0357% --------------------------------------------------------------------------------------------------- Counterirritant
Menthol 3% --------------------------------------------------------------------------------------------------------- Topical analgesic
Histamine DiHydrochloride% ----------------------------------------------------------------------------------- Topical analgesic

INDICATIONS & USAGE SECTION

INDICATIONS
For the temporary relief of minor pain of muscles and joints associated with:

  • Arthritis
  • Simple Backache
  • Strains
  • Sprains
  • Bruises

WARNINGS AND PRECAUTIONS SECTION

WARNINGS
FOR EXTERNAL USE ONLY.

  • Use only as directed
  • Do not bandage tightly
  • Do not use with a heating pad
  • Avoid contact with the eyes or mucous membranes
  • Do not apply to wounds, damaged, broken or irritated skin
  • A transient burning sensation may occur upon application but generally disappears in several days
  • If severe burning sensation occurs, discontinue use immediately and call a doctor
  • Do not expose the area treated with product to heat or direct sunlight

WARNINGS AND PRECAUTIONS SECTION

STOP USE AND ASK A DOCTOR IF:

  • Condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days
  • Redness is present or irritation develops

INDICATIONS & USAGE SECTION

DIRECTIONS

  • Adults and children over 18 years:
  • Apply generously to affected area
  • Massage into painful area until thoroughly absorbed into skin
  • Repeat as necessary, not more than 3-4 times daily.
  • Wash hands with soap and water immediately after use.
  • Children 18 years or younger: ask a doctor

Store at 20°-25°C (68°-77 °F). Avoid direct sunlight.

OTHER SAFETY INFORMATION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

OTHER SAFETY INFORMATION

If pregnant of breast-feeding, ask a healthcare professional before use

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS
aliphatic alcohol; stearic acid; vaseline; peregal; Carmellose; odium; water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SILMANIXRX.jpgSILMANIXRX.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1656333capsaicin 0.0375 % / menthol 3 % / histamine dihydrochloride 0.035 % Topical CreamPSN2
1656333capsaicin 0.375 MG/ML / histamine dihydrochloride 0.35 MG/ML / menthol 30 MG/ML Topical CreamSCD2
1656333capsaicin 0.0375 % / histamine dihydrochloride 0.035 % / menthol 3 % Topical CreamSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69379-013-022020-01-31C16284748780-19d75b9d0-f73f-f424-e053-dadaa90a57ceSilmanix Pain Relieiving Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69379-013-02Simanix120 g in 1 BOTTLECREAM1202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69379-013SIMANIX (SIMANIX PAIN RELIEVING CREAM) CREAM [HOME AIDE DIAGNOSTICS, INC.]2Legacy NDC, 1 package rows20150708_1a4dfef7-a7ac-2142-e054-00144ff8d46c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CAPSAICINACTIVE INGREDIENTS07O44R1ZM2
HISTAMINE DIHYDROCHLORIDEACTIVE INGREDIENT3POA0Q644U2
MENTHOLACTIVE INGREDIENTL7T10EIP3A2
CAPSAICINACTIVE MOIETYS07O44R1ZM2
HISTAMINEACTIVE MOIETY820484N8I32
MENTHOLACTIVE MOIETYL7T10EIP3A2

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69379-01369379-013-02

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
CAPSAICINS07O44R1ZMACTIB
MENTHOLL7T10EIP3AACTIB
HISTAMINE DIHYDROCHLORIDE3POA0Q644UACTIB

Source Document#

Source XML · Source PDF

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
1a4dfef7-a7ad-2142-e054-00144ff8d46c1a4dfef7-a7ac-2142-e054-00144ff8d46c2015-07-07WarningsExact identifier
spl id: 1a4dfef7-a7ad-2142-e054-00144ff8d46c
spl set id: 1a4dfef7-a7ac-2142-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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