FDA Label for Capsaicin Heat
View Indications, Usage & Precautions
Capsaicin Heat Product Label
The following document was submitted to the FDA by the labeler of this product Universal Distribution Center 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.
Otc - Active Ingredient
Active Ingredient
Capsicum Extract Capsaicin 0.025%
Otc - Purpose
Purpose
Topical Analgesic
Indications & Usage
Uses
For temporary relief of minor aches and pains of muscles & joints associated with:
- Simple Backache
- Arthritis
- Strains
- Bruises
- Sprains
Warnings
Warnings
External use only.
Otc - Do Not Use
Do not use
- on wounds or damaged skin
- with a heating pad
- with, or at the same times as other external analgesic
- if you are allergic to any ingredients of this product
Otc - When Using
When using this product
- do not use otherwise than as directed.
- avoid contact with the eyes, mucous membranes or rashes
- do not bandage tightly
- discontinue use at least 1 hour before a bath or shower
- do not use immediately after a bath or shower
Otc - Stop Use
Stop use and ask a doctor if
- rash, itching or excessive skin irritation develops
- conditions worsen
- symptoms persist for more than 7 days
- symptoms clear up and occur again within a few days
Otc - Keep Out Of Reach Of Children
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.
Dosage & Administration
Directions
Adults and Children 12 years of age and over:
- Clean and dry affected area
- Remove patch from film
- Apply to affected area not more than 3 to 4 times daily
- Remove patch from skin after at most 8 hours of application
Children under 12 years of age: Consult a doctor.
Other
Other information
- Avoid storing product in direct sunlight
- Protect product from excessive moisture
Inactive Ingredient
Inactive Ingredients
lanolin, methyl salicylate, natural latex rubber, peppermint oil, petrolatum, rosin, zinc oxide
Package Label.Principal Display Panel
PRINCIPAL DISPLAY PANEL
Capsaicin Heat Patch
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