FDA Label for Capsaicin
View Indications, Usage & Precautions
Capsaicin Product Label
The following document was submitted to the FDA by the labeler of this product Sa3, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
Aqua (Deionized Water), Sodium Polyacrylate, Glycerin, Sorbitol, Sodium Cellulose Glycolate, Polysorbate 80, Lemon Oil, Aluminum Glycinate, Eucalyptus Oil, Methylparaben, EDTA Disodium Salt
Principal Display Panel
Capsaicin 0.025% Patch
NDC 69420-7025-1
10 Patches (5 per Resealable Pouch)
SA3, LLC
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