MEDI-DERM
- Manufacturer
- Two Hip Consulting, LLC
- Effective date
- 2019-02-06
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 7
- Source
- full-release
- Hydrated at
- 2026-05-31 20:27:45
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredients
Capsaicin 0.035%
Menthol 5%
Methyl Salicylate 20%
OTC - PURPOSE SECTION
PURPOSE
TOPICAL ANALGESIC
INDICATIONS & USAGE SECTION
USES: FOR THE TEMPORARY RELIEF OF MINOR ACHES AND PAINS OF MUSCLES AND JOINTS ASSOCIATED WITH ARTHRITIS, SIMPLE BACKACHE, STRAINS, SPRAINS, MUSCLE SORENESS AND STIFFNESS.
WARNINGS SECTION
Warnings: For external use only.
- Use only as directed.
- Avoid contact with eyes and mucous membranes.
- Do not use with heating devices or pads.
- Do not cover or bandage tightly.
- If swallowed, call poison control.
- If contact does occur with eyes rinse with cold water and call a doctor.
OTC - DO NOT USE SECTION
DO NOT USE: ON WOUNDS OR DAMAGED SKIN. CHILDREN UNDER 12 YEARS OLD, CONSULT A DOCTOR. IF YOU ARE ALLERGIC TO ANY INGREDIENTS IN THIS PRODUCT.
DOSAGE & ADMINISTRATION SECTION
Directions: Use only as directed. Prior to first use, test skin sensitivity by applying a small amount. Apply and massage directly to affected area. Do not use more than 4 times a day. Thoroughly wash hands after application.
INACTIVE INGREDIENT SECTION
Inactive Ingredients: Carbomer, Cetearyl Alcohol, Cypress Oil, Glyceryl Stearate, Green 3 (CI# 42053), Hypromellose, Isopropyl Palmitate, Methylisothiazolinone, Phenoxyethanol, Polysorbate-60, Propylene Glycol, Sodium Hydroxide, Stearyl Alcohol, Water.
OTHER SAFETY INFORMATION
OTHER INFORMATION: STORE BELOW 90°F/32°C
OTC - QUESTIONS SECTION
QUESTIONS? 888 907-2833
OTC - ASK DOCTOR SECTION
IF CONDITION WORSENS, OR IF SYMPTOMS PERSIST FOR MORE THAN 7 DAYS OR CLEAR UP AND OCCUR AGAIN WITHIN A FEW DAYS, DISCONTINUE USE OF THIS PRODUCT AND CONSULT A DOCTOR.
PREGNANCY SECTION
IF PREGNANT OR NURSING ASK A HEALTH PROFESSIONAL BEFORE USE.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
KEEP OUT OF REACH OF CHILDREN.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1095682 | capsaicin 0.035 % / menthol 5 % / methyl salicylate 20 % Topical Cream | PSN | 7 |
| 1436369 | Medi-Derm (capsaicin 0.035 % / menthol 5 % / methyl salicylate 20 % ) Topical Cream | PSN | 7 |
| 1436369 | capsaicin 0.35 MG/ML / menthol 50 MG/ML / methyl salicylate 200 MG/ML Topical Cream [Medi-Derm] | SBD | 7 |
| 1095682 | capsaicin 0.35 MG/ML / menthol 50 MG/ML / methyl salicylate 200 MG/ML Topical Cream | SCD | 7 |
| 1095682 | capsaicin 0.035 % / menthol 5 % / methyl salicylate 20 % Topical Cream | SY | 7 |
| 1436369 | Medi-Derm (capsaicin 0.035 % / menthol 5 % / methyl salicylate 20 % ) Topical Cream | SY | 7 |
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 |
|---|---|---|---|---|---|
| 76074-151-14 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-2ef8-a910-e053-dadaa90a0b85 | 95910cee-0a43-4ac9-aeb9-6a659757b3ba |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76074-151-14 | MEDI-DERMRX | 120 mL in 1 TUBE | CREAM | 120 | 7 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 76074-151-14 | ML - Milliliter | 76074-151 | 1c56213a-1bb7-41f4-8b0b-54cc3c38282e | 1 | 2015-10-02 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| CAPSAICIN | ACTIVE INGREDIENT | S07O44R1ZM | 6 | |
| MENTHOL | ACTIVE INGREDIENT | L7T10EIP3A | 6 | |
| METHYL SALICYLATE | ACTIVE INGREDIENT | LAV5U5022Y | 6 | |
| CAPSAICIN | ACTIVE MOIETY | S07O44R1ZM | 6 | |
| MENTHOL | ACTIVE MOIETY | L7T10EIP3A | 6 | |
| SALICYLIC ACID | ACTIVE MOIETY | O414PZ4LPZ | 6 | |
| CARBOMER 934 | INACTIVE INGREDIENT | Z135WT9208 | 6 | |
| CETOSTEARYL ALCOHOL | INACTIVE INGREDIENT | 2DMT128M1S | 6 | |
| CYPERUS ESCULENTUS LEAF | INACTIVE INGREDIENT | T1004HC0OF | 6 | |
| FD&C GREEN NO. 3 | INACTIVE INGREDIENT | 3P3ONR6O1S | 6 | |
| GLYCERYL MONOSTEARATE | INACTIVE INGREDIENT | 230OU9XXE4 | 6 | |
| HYPROMELLOSE 2208 (100000 MPA.S) | INACTIVE INGREDIENT | VM7F0B23ZI | 6 | |
| ISOPROPYL PALMITATE | INACTIVE INGREDIENT | 8CRQ2TH63M | 6 | |
| METHYLISOTHIAZOLINONE | INACTIVE INGREDIENT | 229D0E1QFA | 6 | |
| PHENOXYETHANOL | INACTIVE INGREDIENT | HIE492ZZ3T | 6 | |
| POLYSORBATE 60 | INACTIVE INGREDIENT | CAL22UVI4M | 6 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 6 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | 6 | |
| STEARYL ALCOHOL | INACTIVE INGREDIENT | 2KR89I4H1Y | 6 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 6 |
Products#
Every source-derived product name is available through these pages.
- MEDI-DERM RX
- METHYL SALICYLATE, MENTHOL AND CAPSAICIN
- METHYL SALICYLATE
- SALICYLIC ACID
- MENTHOL
- CAPSAICIN
- CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)
- CETOSTEARYL ALCOHOL
- CYPERUS ESCULENTUS LEAF
- GLYCERYL MONOSTEARATE
- FD&C GREEN NO. 3
- HYPROMELLOSE 2208 (100000 MPA.S)
- ISOPROPYL PALMITATE
- METHYLISOTHIAZOLINONE
- PHENOXYETHANOL
- POLYSORBATE 60
- PROPYLENE GLYCOL
- SODIUM HYDROXIDE
- STEARYL ALCOHOL
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 76074-151 | 76074-151-14 |
Ingredients#
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / DENTAL | 2 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / AURICULAR (OTIC) | 56.55 %w/v | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRATHECAL | 176 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SHAMPOO / TOPICAL | 8 %w/w | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS | ADJ PH | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM / VAGINAL | 1225 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | TABLET, EXTENDED RELEASE / ORAL | 529 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / PARENTERAL | ADJ PH | ||
| HYPROMELLOSE 2208 (100000 MPA.S) | HYPROMELLOSE 2208 (100000 MPA.S) | VM7F0B23ZI | CAPSULE / ORAL | 161 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SUSPENSION / SOFT TISSUE | ADJ PH | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / AURICULAR (OTIC) | 10 %w/v | ||
| CETOSTEARYL ALCOHOL | CETOSTEARYL ALCOHOL | 2DMT128M1S | AEROSOL, FOAM / TOPICAL | 21 mg | ||
| FD&C GREEN NO. 3 | FD&C GREEN NO. 3 | 3P3ONR6O1S | SOLUTION / TOPICAL | NA | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | SUSPENSION / OPHTHALMIC | 0.5 %w/v | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / RECTAL | NA | ||
| POLYSORBATE 60 | POLYSORBATE 60 | CAL22UVI4M | EMULSION / ORAL | 20 mg/1ml | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, EXTENDED RELEASE / ORAL | 9 mg | ||
| FD&C GREEN NO. 3 | FD&C GREEN NO. 3 | 3P3ONR6O1S | TABLET / ORAL | 240 mg | ||
| STEARYL ALCOHOL | STEARYL ALCOHOL | 2KR89I4H1Y | LOTION / TOPICAL | 1140 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTABLE, LIPOSOMAL / INTRAVENOUS | ADJ PH | ||
| STEARYL ALCOHOL | STEARYL ALCOHOL | 2KR89I4H1Y | SUPPOSITORY / VAGINAL | 8.5 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | DISC / TOPICAL | ADJ PH | ||
| CARBOMER 934 | CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) | Z135WT9208 | GEL / TOPICAL | 30 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | LOTION / TOPICAL | 3392 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION/ DROPS / AURICULAR (OTIC) | ADJ PH | ||
| CARBOMER 934 | CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) | Z135WT9208 | OINTMENT / TOPICAL | 0.5 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION, CONCENTRATE / INTRAVENOUS | 50.33 %w/v | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / URETHRAL | ADJ PH | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / RECTAL | 3315 mg | ||
| STEARYL ALCOHOL | STEARYL ALCOHOL | 2KR89I4H1Y | TABLET, EXTENDED RELEASE / ORAL | 244 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SPRAY, METERED / NASAL | 240 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 27 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | FILM / BUCCAL | 1.48 mg | ||
| FD&C GREEN NO. 3 | FD&C GREEN NO. 3 | 3P3ONR6O1S | ELIXIR / ORAL | NA | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | CREAM / TOPICAL | 69 mg | ||
| FD&C GREEN NO. 3 | FD&C GREEN NO. 3 | 3P3ONR6O1S | CAPSULE, COATED PELLETS / ORAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, EXTENDED RELEASE / ORAL | 8 mg | ||
| STEARYL ALCOHOL | STEARYL ALCOHOL | 2KR89I4H1Y | TABLET / ORAL | 20 mg | ||
| CARBOMER 934 | CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) | Z135WT9208 | SUSPENSION / ORAL | 288 mg | ||
| FD&C GREEN NO. 3 | FD&C GREEN NO. 3 | 3P3ONR6O1S | SHAMPOO / TOPICAL | 0.09 %w/w | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | TABLET / SUBLINGUAL | 1.23 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION, CONCENTRATE / INTRAVENOUS | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRASYNOVIAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / INTRATHECAL | ADJ PH | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION, CONCENTRATE / ORAL | 2590 mg | ||
| HYPROMELLOSE 2208 (100000 MPA.S) | HYPROMELLOSE 2208 (100000 MPA.S) | VM7F0B23ZI | LOTION / TOPICAL | 7 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / SOFT TISSUE | ADJ PH | ||
| CARBOMER 934 | CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) | Z135WT9208 | TABLET, EXTENDED RELEASE / ORAL | 90 mg | ||
| FD&C GREEN NO. 3 | FD&C GREEN NO. 3 | 3P3ONR6O1S | CAPSULE / ORAL | 40 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION / ENDOTRACHEAL | ADJ PH | ||
| CARBOMER 934 | CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) | Z135WT9208 | GEL, METERED / TRANSDERMAL | 1 %w/w | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / URETERAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / IRRIGATION | ADJ PH | ||
| CETOSTEARYL ALCOHOL | CETOSTEARYL ALCOHOL | 2DMT128M1S | CREAM / VAGINAL | 6 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRACAVITARY | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | TABLET, COATED / ORAL | NA | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRABURSAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION / AURICULAR (OTIC) | ADJ PH | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | GEL / TOPICAL | 14 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, FOAM / TOPICAL | 1800 mg |
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 |
|---|---|---|---|---|---|---|
| cc2d7592-626d-47c3-aaca-211615622dfa | 95910cee-0a43-4ac9-aeb9-6a659757b3ba | 2019-02-06 | Warnings | cc2d7592-626d-47c3-aaca-211615622dfa 95910cee-0a43-4ac9-aeb9-6a659757b3ba |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
