Silmanix Pain Relieiving Cream
- Manufacturer
- Home Aide Diagnostics, Inc. | Zhejiang Bangli Medical Products Co. Ltd
- Effective date
- 2015-07-07
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-05-31 22:42:55
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
OTC - PURPOSE SECTION
PURPOSE: Topical analgesic
OTC - ACTIVE INGREDIENT SECTION
ACTIVE INGREDIENTS
Histamine Dihydrochloride 0.035% ---------------------------------------------------------------------------------Topical analgesic
Menthol 3% --------------------------------------------------------------------------------------------------------- Topical analgesic
Capsaicin 0.0375% ------------------------------------------------------------------------------------------------- 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 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
DOSAGE & ADMINISTRATION 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.
OTC - STOP USE 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
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant of breast-feeding, ask a healthcare professional before use
INACTIVE INGREDIENT SECTION
INACTIVE INGREDIENTS
aliphatic alcohol; stearic acid; vaseline; peregal; Carmellose Sodium; water;
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0169379012011 | GTIN-13: 0169379012011 EAN-13: 0169379012011 GTIN-12: 169379012011 UPC-A: 169379012011 GTIN storage (14 digits): 00169379012011 | SILMANIX.jpg |
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 |
|---|---|---|---|---|---|
| 69379-012-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-ef0c-f424-e053-dadaa90a57ce | Silmanix Pain Relieiving Cream |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69379-012-01 | Rematex | 120 g in 1 BOTTLE, PUMP | CREAM | 120 | 4 |
DailyMed Dashboard NDC Coverage#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| CAPSAICIN | ACTIVE INGREDIENT | S07O44R1ZM | 4 | |
| HISTAMINE DIHYDROCHLORIDE | ACTIVE INGREDIENT | 3POA0Q644U | 4 | |
| MENTHOL | ACTIVE INGREDIENT | L7T10EIP3A | 4 | |
| CAPSAICIN | ACTIVE MOIETY | S07O44R1ZM | 4 | |
| HISTAMINE | ACTIVE MOIETY | 820484N8I3 | 4 | |
| MENTHOL | ACTIVE MOIETY | L7T10EIP3A | 4 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 4 |
Products#
Every source-derived product name is available through these pages.
- Rematex
- Rematex Pain RelievingCream
- STEARIC ACID
- MENTHOL
- HISTAMINE DIHYDROCHLORIDE
- HISTAMINE
- CAPSAICIN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69379-012 | 69379-012-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| STEARIC ACID | 4ELV7Z65AP | IACT |
| MENTHOL | L7T10EIP3A | ACTIB |
| HISTAMINE DIHYDROCHLORIDE | 3POA0Q644U | ACTIB |
| CAPSAICIN | S07O44R1ZM | ACTIB |
Source Document#
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.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | IMPLANT / SUBCUTANEOUS | 1.04 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | POWDER, FOR SUSPENSION / ORAL | 1203 mg/5ml | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CAPSULE, EXTENDED RELEASE / ORAL | 64 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | AEROSOL, FOAM / VAGINAL | 4 %w/w | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | PELLET / SUBCUTANEOUS | 0.97 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / BUCCAL | 6 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | SOAP / TOPICAL | 6 %w/w | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED / ORAL | 176 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, DELAYED RELEASE / ORAL | 80 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CREAM / TOPICAL | 190 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | OINTMENT / TOPICAL | 15 %w/w | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CREAM / VAGINAL | 1088 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, COATED / ORAL | 42.4 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | SOLUTION / TOPICAL | NA | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | LOTION / TOPICAL | 80 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CAPSULE / ORAL | 90 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 120 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, EXTENDED RELEASE / ORAL | 200 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | EMULSION / TOPICAL | NA | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, CHEWABLE / ORAL | 180 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | SHAMPOO / TOPICAL | 9.7 %w/w | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / SUBLINGUAL | 9 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / ORAL | 336 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, ORALLY DISINTEGRATING / ORAL | 10 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | AEROSOL, FOAM / TOPICAL | 8 %w/w | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | EMULSION / ORAL | NA |
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 |
|---|---|---|---|---|---|---|
| 1a4c0e56-b4cb-682b-e054-00144ff88e88 | 1a4cf25c-8e83-68c8-e054-00144ff8d46c | 2015-07-07 | Warnings | 1a4c0e56-b4cb-682b-e054-00144ff88e88 1a4cf25c-8e83-68c8-e054-00144ff8d46c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
