FDA Label for Coralite Capsaicin Heat Patch 2ct
View Indications, Usage & Precautions
Coralite Capsaicin Heat Patch 2ct Product Label
The following document was submitted to the FDA by the labeler of this product United Exchange Corp.. 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 Purpose
Capsicum Extract Capsaicin 0.025%..............................Topical Analgesic
Otc - Purpose
Uses
For temporary relief of minor aches and pains of muscles & joints associated with:
- Simple Backache
- Arthritis
- Strains
- Bruises
- Sprains
Warnings
Warnings
For external use only
Allergy alert:
- do not use if you are allergic to capsicum, chili peppers, or any ingredients in this product
- if prone to allergic reaction from aspirin or salicylates, consult a doctor before use
Otc - Do Not Use
Do not use:
on wounds or damaged skin.
with a heating pad.
Otc - When Using
When using this product:
do not use otherwise than 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:
condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days
redness is present or irritation or rash develops
a severe burning sensation occurs
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, ask a health professional before use.
Indications & Usage
Directions
- adults and children 12 years of age and older:
- clean and dry affected area
- remove patch from film
- apply to affected area no more than 3 to 4 times daily
- do not wear patch more than 8 hours
- children under 12 years of age: consult a doctor
Storage And Handling
Other information
- Avoid storing product in direct sunlight.
- Protect product from excessive moisture.
Inactive Ingredient
Inactive ingredients
butylated hydroxytoluene, diphenhydramine, hydrochloride, glyceryl, rosinate, lanolin, natural rubber, petrolatum, polyisobutylene (85,000 MW), styrene-isoprene-styrene block copolymer, titanium dioxide, zinc oxide
Dosage & Administration
Distributed by:
United Exchange Corp.
5836 Corporate Ave.
Cypress, CA 90630 USA
Made in China
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