Indications and uses
Temporarily relieves minor aches and pains of muscles and joints due to: • simple backache • arthritis • strains • sprains
Capsaicin 0_035 Percent Cream
- Manufacturer
- Alexso, Inc
- Effective date
- 2026-02-13
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 01:43:58
Label at a glance#
ProductCapsaicin 0.035 Percent
Active ingredientCAPSAICIN
Label structure9 sections
Dosage and administration
Adults and children 18 years of age and older: Apply a thin film of cream to affected area and gently rub in until fully absorbed unless treating hands. Wash hands thoroughly with soap and water immediately after application for best results. Apply 3 to 4 times daily. Children under 18 years : Ask a doctor
Storage and handling
Store at room temperature 15°-30°C (59°-86°F)
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient
Capsaicin 0.035%
Purpose
External analgesic
Uses
Temporarily relieves minor aches and pains of muscles and joints due to:
• simple backache
• arthritis
• strains
• sprains
Warnings
For external use only
Read all warnings and directions before use. Test first on small area of skin.
Do not use
• On wounds or damaged skin
• If you are allergic to capsicum or chili peppers
When using this product
• You may experience a burning sensation. The intensity of this reaction varies among individuals and may be severe. With regular use, this sensation generally disappears after several days.
• Avoid contact with the eyes, lips, nose and mucous membranes
• Do not tightly wrap or bandage the treated area
• Do not apply heat to the treated area immediately before or after use
Stop use and ask a doctor if
• Condition worsens or does not improve after regular use
• Severe burning persists or blistering occurs
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center immediately.
Directions
Adults and children 18 years of age and older:
Apply a thin film of cream to affected area and gently rub in until fully absorbed unless treating hands. Wash hands thoroughly with soap and water immediately after application for best results. Apply 3 to 4 times daily.
Children under 18 years: Ask a doctor
Other information
Store at room temperature 15°-30°C (59°-86°F)
Inactive ingredients
Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cetearyl Alcohol, Chondroitin Sulfate, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, C13-14 Isoparaffin, Isostearyl Palmitate, Laureth-7, Methylsufonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Sodium Polyacrylate, Stearic Acid, and Triethanolamine
Principal Display Panel
Capsaicin 0.035% cream
NDC 50488-1035-1
Net Wt. 100 g
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 473d070d-1c38-488e-b991-c4d1bf45aab8 | Product name | 1 | 20210201 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50488-1035-1 | Capsaicin 0.035 Percent | 120 g in 1 BOTTLE | CREAM | 120 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50488-1035-1 | GM - Gram | 50488-1035 | 41964388-d8a5-429d-8c3a-dccbbb9de672 | 1 | 2026-04-20 |
Products#
Every source-derived product name is available through these pages.
- Capsaicin 0.035 Percent
- Capsaicin
- WATER
- ARNICA MONTANA FLOWER
- BOSWELLIA SERRATA WHOLE
- CETOSTEARYL ALCOHOL
- CHONDROITIN SULFATE (BOVINE)
- ETHYLHEXYLGLYCERIN
- GLUCOSAMINE SULFATE
- GLYCERIN
- GLYCERYL MONOSTEARATE
- C13-14 ISOPARAFFIN
- ISOSTEARYL PALMITATE
- LAURETH-7
- DIMETHYL SULFONE
- PEG-100 STEARATE
- PHENOXYETHANOL
- POLYACRYLAMIDE (10000 MW)
- PROPYLENE GLYCOL
- SODIUM POLYACRYLATE (2500000 MW)
- STEARIC ACID
- TROLAMINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50488-1035 | 50488-1035-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 1 | 2025-09-16 | monthly-update | 2026-06-03 17:39:29 |
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 |
|---|---|---|---|---|---|---|
| Capsaicin 0.035 Percent | CAPSAICIN | Alexso, Inc | 6d0bc1cc-e812-4753-b20c-c0357dd6deb5 | 2026-02-13 | Warnings | 50488-1035-1 50488-1035 50488103501 e2a30b7f-bcde-4a77-bcbd-3e965d4f8004 6d0bc1cc-e812-4753-b20c-c0357dd6deb5 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.