Dosage and administration
Use only as directed. Adults and children 2 years of age or older: apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a physician.
Use only as directed. Adults and children 2 years of age or older: apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a physician.
Drug Facts
| Active Ingredients | Purpose |
|---|---|
| Capsaicin 0.025% | Topical Analgesic |
| Menthol 2.0% | Topical Analgesic |
| Methyl Salicylate 10% | Topical Analgesic |
Water (Aqua), Stearic Acid, Isopropyl Palmitate, Propylene Glycol, Cetyl Alcohol, Glyceryl Monostearate, Thiethanolamine, Stearyl Alcohol, Polysorbate 60, Phenoxyethanol, Carbomer, Methylparaben, Propylparaben, Sorbitan Sesquioleate, Tetra Sodium EDTA.
Distributed by
Newhall Laboratories, Inc.
5 High Ridge Park, Suite 100
Stamford, CT 06905
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1721014 | capsaicin 0.025 % / menthol 2 % / methyl salicylate 10 % Topical Cream | PSN | 1 |
| 1721014 | capsaicin 0.25 MG/ML / menthol 20 MG/ML / methyl salicylate 100 MG/ML Topical Cream | SCD | 1 |
| 1721014 | capsaicin 0.025 % / menthol 2 % / methyl salicylate 10 % Topical Cream | SY | 1 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 473d070d-1c38-488e-b991-c4d1bf45aab8 | Product name | 1 | 20210201 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 31774-8005-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-d702-f424-e053-dadaa90a57ce | LaBella™ Linimento Obrero |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 31774-8005-1 | LaBella Linimento Obrero | 236 mL in 1 BOTTLE, PLASTIC | CREAM | 236 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 31774-8005 | LABELLA LINIMENTO OBRERO (CAPSAICIN, MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE) CREAM [GOLDEN SUN INC DBA NEWHALL LABORATORIES] | 1 | Legacy NDC, 1 package rows | 20151110_fc5abe34-edf6-400a-bd28-1aea8bac8c70.zip |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Capsaicin | ACTIVE INGREDIENT | S07O44R1ZM | 1 | |
| Menthol, Unspecified Form | ACTIVE INGREDIENT | L7T10EIP3A | 1 | |
| Methyl Salicylate | ACTIVE INGREDIENT | LAV5U5022Y | 1 | |
| Capsaicin | ACTIVE MOIETY | S07O44R1ZM | 1 | |
| Menthol, Unspecified Form | ACTIVE MOIETY | L7T10EIP3A | 1 | |
| Salicylic Acid | ACTIVE MOIETY | O414PZ4LPZ | 1 | |
| Cetyl Alcohol | INACTIVE INGREDIENT | 936JST6JCN | 1 | |
| Edetate Sodium | INACTIVE INGREDIENT | MP1J8420LU | 1 | |
| Glyceryl Monostearate | INACTIVE INGREDIENT | 230OU9XXE4 | 1 | |
| Isopropyl Palmitate | INACTIVE INGREDIENT | 8CRQ2TH63M | 1 | |
| Methylparaben | INACTIVE INGREDIENT | A2I8C7HI9T | 1 | |
| Phenoxyethanol | INACTIVE INGREDIENT | HIE492ZZ3T | 1 | |
| Polysorbate 60 | INACTIVE INGREDIENT | CAL22UVI4M | 1 | |
| Propylene Glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| Propylparaben | INACTIVE INGREDIENT | Z8IX2SC1OH | 1 | |
| Sorbitan Sesquioleate | INACTIVE INGREDIENT | 0W8RRI5W5A | 1 | |
| Stearic Acid | INACTIVE INGREDIENT | 4ELV7Z65AP | 1 | |
| Stearyl Alcohol | INACTIVE INGREDIENT | 2KR89I4H1Y | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 31774-8005 | 31774-8005-1 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Capsaicin | S07O44R1ZM | ACTIB |
| Menthol, Unspecified Form | L7T10EIP3A | ACTIB |
| Methyl Salicylate | LAV5U5022Y | ACTIB |
| Water | 059QF0KO0R | IACT |
| Stearic Acid | 4ELV7Z65AP | IACT |
| Isopropyl Palmitate | 8CRQ2TH63M | IACT |
| Propylene Glycol | 6DC9Q167V3 | IACT |
| Cetyl Alcohol | 936JST6JCN | IACT |
| Glyceryl Monostearate | 230OU9XXE4 | IACT |
| Stearyl Alcohol | 2KR89I4H1Y | IACT |
| Polysorbate 60 | CAL22UVI4M | IACT |
| Phenoxyethanol | HIE492ZZ3T | IACT |
| Methylparaben | A2I8C7HI9T | IACT |
| Propylparaben | Z8IX2SC1OH | IACT |
| Sorbitan Sesquioleate | 0W8RRI5W5A | IACT |
| Edetate Sodium | MP1J8420LU | IACT |
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 |
|---|---|---|---|---|---|---|
| Edetate Sodium | EDETATE SODIUM | MP1J8420LU | SHAMPOO / TOPICAL | 1.33 %w/w | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | IMPLANT / SUBCUTANEOUS | 1.04 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION / SUBCUTANEOUS | 1.4 %w/v | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION / INTRAMUSCULAR | 95 mg | ||
| Edetate Sodium | EDETATE SODIUM | MP1J8420LU | CAPSULE / ORAL | 1 mg | ||
| Propylparaben | PROPYLPARABEN | Z8IX2SC1OH | JELLY / TOPICAL | 180 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SPRAY / NASAL | 5 mg | ||
| Propylparaben | PROPYLPARABEN | Z8IX2SC1OH | SPRAY / TOPICAL | 0.8 %w/w | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / OPHTHALMIC | 1 %w/v | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | EMULSION / OPHTHALMIC | 1.5 %w/v | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | EMULSION / ORAL | NA | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, DELAYED RELEASE / ORAL | 1.7 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SHAMPOO, SUSPENSION / TOPICAL | 2 %w/w | ||
| Glyceryl Monostearate | GLYCERYL MONOSTEARATE | 230OU9XXE4 | CAPSULE / ORAL | 13.75 mg | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | TABLET, DELAYED RELEASE / ORAL | 80 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SPONGE / TOPICAL | 40 %w/w | ||
| Cetyl Alcohol | CETYL ALCOHOL | 936JST6JCN | AEROSOL, FOAM / TOPICAL | 82 mg | ||
| Propylparaben | PROPYLPARABEN | Z8IX2SC1OH | OINTMENT / TOPICAL | 0.2 %w/w | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION / INTRAMUSCULAR | 7459 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / ORAL | 27120 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, COATED / ORAL | 25 mg | ||
| Propylparaben | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / NASAL | 140 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / RECTAL | 1808 mg | ||
| Polysorbate 60 | POLYSORBATE 60 | CAL22UVI4M | CREAM / VAGINAL | 200 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT / TOPICAL | 5148 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 15 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | OINTMENT / OPHTHALMIC | 0.05 %w/w | ||
| Propylparaben | PROPYLPARABEN | Z8IX2SC1OH | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 0.8 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / ORAL | 22602 mg | ||
| Polysorbate 60 | POLYSORBATE 60 | CAL22UVI4M | SUPPOSITORY / RECTAL | 0.05 mg/mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / ORAL | 388 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, METERED / RECTAL | NA | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION/ DROPS / OPHTHALMIC | 0.75 %w/v | ||
| Stearyl Alcohol | STEARYL ALCOHOL | 2KR89I4H1Y | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 120 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION / INTRADERMAL | 1 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | JELLY / NASAL | 250 mg | ||
| Cetyl Alcohol | CETYL ALCOHOL | 936JST6JCN | EMULSION / TOPICAL | NA | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SUPPOSITORY / VAGINAL | 252 mg | ||
| Propylparaben | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION, EXTENDED RELEASE / ORAL | 4 mg | ||
| Glyceryl Monostearate | GLYCERYL MONOSTEARATE | 230OU9XXE4 | TABLET, EXTENDED RELEASE / ORAL | 529 mg | ||
| Stearyl Alcohol | STEARYL ALCOHOL | 2KR89I4H1Y | OINTMENT / TOPICAL | 569 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / RECTAL | 3315 mg | ||
| Propylparaben | PROPYLPARABEN | Z8IX2SC1OH | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 0.4 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | POWDER, FOR SUSPENSION / ORAL | 75 mg | ||
| Stearyl Alcohol | STEARYL ALCOHOL | 2KR89I4H1Y | POWDER / ORAL | 0.11 mg | ||
| Propylparaben | PROPYLPARABEN | Z8IX2SC1OH | FILM / BUCCAL | 0.22 mg | ||
| Propylparaben | PROPYLPARABEN | Z8IX2SC1OH | TABLET, COATED / ORAL | 0.8 mg | ||
| Cetyl Alcohol | CETYL ALCOHOL | 936JST6JCN | TABLET / ORAL | NA | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | FILM, SOLUBLE / BUCCAL | 5 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | ELIXIR / ORAL | 800 mg | ||
| Propylparaben | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION / RECTAL | 271 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, FOAM / VAGINAL | 6.4 %w/w | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | ENEMA / RECTAL | 0.18 %w/v | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | FILM / BUCCAL | 1 mg | ||
| Cetyl Alcohol | CETYL ALCOHOL | 936JST6JCN | AEROSOL, FOAM / VAGINAL | 0.75 %w/w | ||
| Polysorbate 60 | POLYSORBATE 60 | CAL22UVI4M | GUM, CHEWING / BUCCAL | 5 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM / VAGINAL | 1225 mg | ||
| Propylparaben | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / PARENTERAL | 2 mg | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | SHAMPOO / TOPICAL | 9.7 %w/w | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, COATED / ORAL | 16 mg |
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 |
|---|---|---|---|---|---|---|
| 12bf2514-2813-46c3-a3b4-c3425cbeb162 | fc5abe34-edf6-400a-bd28-1aea8bac8c70 | 2015-11-06 | Warnings | 12bf2514-2813-46c3-a3b4-c3425cbeb162 fc5abe34-edf6-400a-bd28-1aea8bac8c70 |
Adverse event summaries are temporarily unavailable. Other product information remains available.