Indications and uses
Temporarily relieves minor aches and pains of muscles and joints due to: • simple backache • arthritis • strains • sprains
Capsaicin Cream
- Manufacturer
- 7T Pharma LLC
- Effective date
- 2019-10-23
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 00:06:49
Label at a glance#
ProductCapsaicin
Active ingredientCAPSAICIN
Label structure11 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
CAPSAICIN – Capsaicin 0.025% Cream
7T Pharma, 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.
----------
Capsaicin 0.025% Cream
Drug Facts
Active ingredient
Capsaicin 0.025%
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 0.025% cream
NDC 70645-025-25
25 grams
PRINCIPAL DISPLAY PANEL
Capsaicin 0.025% cream
NDC 70645-025-50
50 grams
PRINCIPAL DISPLAY PANEL
Capsaicin 0.025% cream
NDC 70645-025-12
120 grams
7T Pharma, LLC
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 70645-025-12 | 2024-03-06 | C162847 | 48780-1 | ba0f9c33-1f8e-a910-e053-dadaa90a0b85 | Capsaicin Cream |
| 70645-025-25 | 2024-03-06 | C162847 | 48780-1 | ba0f9c33-1f8e-a910-e053-dadaa90a0b85 | Capsaicin Cream |
| 70645-025-50 | 2024-03-06 | C162847 | 48780-1 | ba0f9c33-1f8e-a910-e053-dadaa90a0b85 | Capsaicin Cream |
| 70645-025-12 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-1f8e-a910-e053-dadaa90a0b85 | Capsaicin Cream |
| 70645-025-25 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-1f8e-a910-e053-dadaa90a0b85 | Capsaicin Cream |
| 70645-025-50 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-1f8e-a910-e053-dadaa90a0b85 | Capsaicin Cream |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70645-025-12 | GM - Gram | 70645-025 | 4c63c861-51fd-4c07-890b-97ee106ba24f | 1 | 2019-11-12 |
| 70645-025-25 | GM - Gram | 70645-025 | 54a13e5b-1735-4141-86b4-71f533c4fa7f | 1 | 2019-11-12 |
| 70645-025-50 | GM - Gram | 70645-025 | c44861d1-bace-4010-80e8-d1c77667b5cf | 1 | 2019-11-12 |
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 |
|---|---|
| 70645-025 | 70645-025-12, 70645-025-25, 70645-025-50 |
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 |
|---|---|---|---|---|---|---|
| d3c38e2f-3e40-42cb-a8f8-0660b3604b8f | 5a02f59e-6f92-4284-aa3f-a16ad289876c | 2024-03-08 | Warnings | 5a02f59e-6f92-4284-aa3f-a16ad289876c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.