Indications and uses
Temporarily relieves minor aches and pains of muscles and joints due to: • arthritis • simple backache • strains • bruises • sprains
Capsaicin Patch
- Manufacturer
- FORREAL PHARMACEUTICALS LLC
- Effective date
- 2022-08-30
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:54:49
Label at a glance#
ProductCapsaicin
Active ingredientCAPSAICIN
Label structure9 sections
Dosage and administration
Adults and children 18 years of age and older: Apply 1 patch to the affected area of intact skin up to 3 times a day. Do not leave patch on for more than 8 hours at a time. Clean and dry the affected area. Open pouch and remove one patch. Remove any protective film and apply directly to affected area of pain. Apply immediately after removal from the protective envelope. Wash hands with soap and water after handlin...
Storage and handling
Store at room temperature 15°-30°C (59°-86°F)
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
CAPSAICIN – Capsaicin 0.025% Patch
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% Patch
Drug Facts
Active ingredient
Capsaicin 0.025%
Purpose
External analgesic
Uses
Temporarily relieves minor aches and pains of muscles and joints due to:
• arthritis
• simple backache
• strains
• bruises
• sprains
Warnings
For external use only. Use only as directed or as directed by a health care professional
Read all warnings and directions before use.
Discontinue use at least one hour prior to bath, shower, or swimming; do not use immediately after bath, shower, or swimming.
Do not use
• On wounds, cuts, damaged or infected skin
• On eyes, mouth, genitals, or any other mucous membranes
Allergy Alert: if you are allergic to capsicum or chili peppers or any inactive ingredient of this product, contact a doctor before use.
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 physician:
• If pregnant or breast feeding
• 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 physician.
• If severe burning persists or blistering occurs
Keep out of reach of children and pets.
If swallowed, get medical help or contact a Poison Control Center immediately.
Directions
Adults and children 18 years of age and older:
Apply 1 patch to the affected area of intact skin up to 3 times a day. Do not leave patch on for more than 8 hours at a time.
- Clean and dry the affected area.
- Open pouch and remove one patch.
- Remove any protective film and apply directly to affected area of pain. Apply immediately after removal from the protective envelope.
- Wash hands with soap and water after handling the patches.
- Reseal pouch containing unused patches after each use. Do not store patch outside the sealed envelope.
- Fold used patches so that the adhesive side sticks to itself and safely discard used patches or pieces of cut patches where children and pets cannot get to them.
Children under 18 years: Ask a physician
Other information
Store at room temperature 15°-30°C (59°-86°F)
Inactive ingredients
Glycerin, Sodium polyacrylate, Dihydroxyaluminum aminoacetate, Edetate disodium, Kaolin, Carboxymethylcellulose sodium, Titanium dioxide, L-Tartaric acid, Polyacrylic acid, Capsaicin, Propylene glycol, Polysorbate 80, Petrolatum, Hydroxyacetophenone, Water, PVP
PRINCIPAL DISPLAY PANEL
NDC 81877-515-15
Qty: 15 Patches
(5 per Resealable Pouch) x 3
Capsaicin 0.025%
Topical Pain Patch
for temporary pain relief
Forreal Pharmaceuticals LLC
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 81877-515-15 | 2025-01-09 | C162847 | 48780-1 | 1030e365-1abc-111a-e063-dadaa90a10e2 | Capsaicin Patch |
| 81877-515-15 | 2024-01-30 | C162847 | 48780-1 | 1030e365-1abc-111a-e063-dadaa90a10e2 | Capsaicin Patch |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 81877-515-15 | EA - Each | 81877-515 | 0c4a80ef-8fa9-4fa5-8296-7b11940c855b | 1 | 2022-09-12 |
Products#
Every source-derived product name is available through these pages.
- Capsaicin
- GLYCERIN
- SODIUM POLYACRYLATE (8000 MW)
- DIHYDROXYALUMINUM AMINOACETATE
- EDETATE DISODIUM
- KAOLIN
- CARBOXYMETHYLCELLULOSE SODIUM
- TITANIUM DIOXIDE
- TARTARIC ACID
- POLYACRYLIC ACID (8000 MW)
- POLYSORBATE 80
- PETROLATUM
- HYDROXYACETOPHENONE
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 81877-515 | 81877-515-15 |
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 |
|---|---|---|---|---|---|---|
| 3e56ced9-2d51-47f9-8af1-a82e41fe8df4 | e4d301fd-74d6-4312-9049-3ee1564f2bbb | 2025-01-08 | Warnings | e4d301fd-74d6-4312-9049-3ee1564f2bbb |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.