Indications and uses
Temporarily relieves minor aches and pains of muscles and joints due to: • simple backache • arthritis • strains • sprains
Capsaicin Cream
- Manufacturer
- SA3, LLC
- Effective date
- 2024-12-09
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 00:40:53
Label at a glance#
ProductCapsaicin
Active ingredientCAPSAICIN
Label structure10 sections
Dosage and administration
Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Wash hands thoroughly with soap and water immediately after application. Children under 2 years : consult a doctor
Storage and handling
Store at room temperature 15°-30°C (59°-86°F). Protect the product from excessive heat and direct sun.
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
CAPSAICIN – Capsaicin 0.025% Cream
SA3, LLC
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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Capsaicin 0.025% Cream
Drug Facts
Active ingredient
Capsaicin 0.025%
Purpose
Topical 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
• Apply to wounds or damaged skin
• Bandage tightly
• 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 if symptoms persist for more than 7 days or clear up and occur again within a few days
• Severe burning persists or blistering occurs
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center immediately. If pregnant or breast-feeding, ask a health professional before use.
Directions
Adults and children 2 years of age and older:
Apply to affected area not more than 3 to 4 times daily. Wash hands thoroughly with soap and water immediately after application.
Children under 2 years: consult a doctor
Other information
Store at room temperature 15°-30°C (59°-86°F). Protect the product from excessive heat and direct sun.
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 0.025% cream
NDC 69420-6025-5
50 grams
SA3, LLC
PRINCIPAL DISPLAY PANEL
Capsaicin 0.025% cream
NDC 69420-6025-1
120 grams
SA3, LLC
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 |
|---|---|---|---|---|---|---|
| 69420-6025-1 | Capsaicin | 120 g in 1 TUBE | CREAM | 120 | 3 | |
| 69420-6025-5 | Capsaicin | 50 g in 1 TUBE | CREAM | 50 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 69420-6025 | CAPSAICIN CREAM [SA3, LLC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20241208_5617e91d-e650-4a0d-8565-b8288ea41c77.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 69420-6025-1 | GM - Gram | 69420-6025 | 3e049330-1343-472b-be21-0ea6035dd02e | 1 | 2022-09-12 |
| 69420-6025-5 | GM - Gram | 69420-6025 | ab9ab90e-6e51-406f-820b-245828ca9187 | 1 | 2021-08-05 |
Products#
Every source-derived product name is available through these pages.
- Capsaicin
- WATER
- ARNICA MONTANA FLOWER
- INDIAN FRANKINCENSE
- CETOSTEARYL ALCOHOL
- ETHYLHEXYLGLYCERIN
- GLUCOSAMINE SULFATE
- GLYCERIN
- GLYCERYL MONOSTEARATE
- C13-14 ISOPARAFFIN
- ISOSTEARYL PALMITATE
- LAURETH-7
- DIMETHYL SULFONE
- PEG-100 STEARATE
- PHENOXYETHANOL
- PROPYLENE GLYCOL
- STEARIC ACID
- TROLAMINE
- CHONDROITIN SULFATE (BOVINE)
- POLYACRYLAMIDE (10000 MW)
- SODIUM POLYACRYLATE (2500000 MW)
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69420-6025 | 69420-6025-5, 69420-6025-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| Capsaicin | CAPSAICIN | SA3, LLC | 5617e91d-e650-4a0d-8565-b8288ea41c77 | 2024-12-09 | Warnings | 69420-6025-5 69420-6025-1 69420-6025 69420602505 69420602501 985b88b0-bf00-4651-83b2-7ced79a33b69 5617e91d-e650-4a0d-8565-b8288ea41c77 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.