FDA Label for Coralite Pain Relief Hot
View Indications, Usage & Precautions
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- WARNINGS
- OTC - DO NOT USE
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- DOSAGE & ADMINISTRATION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Coralite Pain Relief Hot Product Label
The following document was submitted to the FDA by the labeler of this product United Exchange Corporation. 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
Drug Facts
Active ingredient Purpose
Capsicum extract 0.083% as Capsaicin........Topical analgesic
Menthol 3%....................................................Topical analgesic
Otc - Purpose
Uses
temporarily relieves minor pain of muscles and joints associated with:
- arthritis
- simple backache
- strains
- sprains
- bruises
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.
Otc - Do Not Use
Do not use
- on wounds or damaged skin
- with a heating pad
Otc - When Using
When using this product
- use only 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
- 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 - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
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.
Indications & Usage
Directions
- adults and children 18 years of age and older:
- clean and dry affected area
- remove patch from film
- apply to affected area not more than 3 to 4 times daily
- removed patch from the skin after 8 hours application
- children under 12 years of age: ask a doctor
Storage And Handling
Other information
- avoid storing product in direct sunlight
- protect product from excessive moisture
Inactive Ingredient
Inactive ingredients alcohol, aluminum glycinate, glycerin, kalin, methylparaben, polysorbate 80, propylparaben, purified water, sodium polyacrylate, sorbitan monooleate, tartaric acid, titanium dioxide
Otc - Questions
Questions or comments?
Call 1-800-814-8028 monday-Friday 9AM-5PM (PST)
Dosage & Administration
Distributed By: UNITED EXCHANGE CORPORATION
Cypress, CA 90630 USA | 1-888-645-8204
Made In China
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