FDA Label for Coralite Muscle And Joint Pain Relief
View Indications, Usage & Precautions
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- 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 Muscle And Joint Pain Relief 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
Active Ingredients Purposes
Camphor 1.2%...................Topical analgesic
Menthol 5.7%.....................Topical analgesic
Methyl salicylate 6.3%.......Topical analgesic
Otc - Purpose
Uses
- temporarily relieves the minor aches and pains of muscles and joints associated with:
- sprains
- simple backache
- arthritis
- strains
- bruises
Warnings
For external use only
Allergy alert: 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
- if you are allergic to any ingredients of this product
- on a child under 12 years of age with arthritis-like conditions
Otc - Ask Doctor
Ask a doctor before use if you have redness over the affected area.
Otc - When Using
When using this product
- do not use otherwise than as directed
- avoid contact with 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
- redness is present or irritation or rash develops
- conditioin worsens or symptoms persist for more than 7 days
- symptoms clear up and occur again within a few days
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 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 for more than 4 hours
- children under 12 years of age: consult a doctor
Storage And Handling
- store at room temperature 20-25°C (68-77°F)
- avoid storing product in direct sunlight
- protect product from excessive moisture
Inactive Ingredient
Inactive ingredients
aluminum silicate, butylated hydroxytoluene, glyceryl rosinate, lanolin, natural rubber, paraffin, polyisobutylene (80000 mw), polyisobutylene (85000 mw), styrene-isoprene-styrene block copolymer, titanium dioxide, zinc oxide
Otc - Questions
Call 1-888-645-8204 Monday-Friday 9AM-5PM (PST)
Dosage & Administration
Distributed By:
UNITED EXCHANGE CORP.
Cypress, CA. 90630 USA
Made in China
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