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#
Contacts and useful links#
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
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1656333 | capsaicin 0.0375 % / menthol 3 % / histamine dihydrochloride 0.035 % Topical Cream | PSN | 2 |
| 1656333 | capsaicin 0.375 MG/ML / histamine dihydrochloride 0.35 MG/ML / menthol 30 MG/ML Topical Cream | SCD | 2 |
| 1656333 | capsaicin 0.0375 % / histamine dihydrochloride 0.035 % / menthol 3 % Topical Cream | SY | 2 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 473d070d-1c38-488e-b991-c4d1bf45aab8 | Product name | 1 | 20210201 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69379-013-02 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f73f-f424-e053-dadaa90a57ce | Silmanix Pain Relieiving Cream |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69379-013-02 | Simanix | 120 g in 1 BOTTLE | CREAM | 120 | 2 |
DailyMed Dashboard NDC Coverage#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| CAPSAICIN | ACTIVE INGREDIENT | S07O44R1ZM | 2 | |
| HISTAMINE DIHYDROCHLORIDE | ACTIVE INGREDIENT | 3POA0Q644U | 2 | |
| MENTHOL | ACTIVE INGREDIENT | L7T10EIP3A | 2 | |
| CAPSAICIN | ACTIVE MOIETY | S07O44R1ZM | 2 | |
| HISTAMINE | ACTIVE MOIETY | 820484N8I3 | 2 | |
| MENTHOL | ACTIVE MOIETY | L7T10EIP3A | 2 |
Products#
Every source-derived product name is available through these pages.
- Simanix
- Simanix Pain Relieving Cream
- CAPSAICIN
- MENTHOL
- HISTAMINE DIHYDROCHLORIDE
- HISTAMINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69379-013 | 69379-013-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CAPSAICIN | S07O44R1ZM | ACTIB |
| MENTHOL | L7T10EIP3A | ACTIB |
| HISTAMINE DIHYDROCHLORIDE | 3POA0Q644U | ACTIB |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 1a4dfef7-a7ad-2142-e054-00144ff8d46c | 1a4dfef7-a7ac-2142-e054-00144ff8d46c | 2015-07-07 | Warnings | 1a4dfef7-a7ad-2142-e054-00144ff8d46c 1a4dfef7-a7ac-2142-e054-00144ff8d46c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
