FDA Label for Xtracare Ice Cold Topical Analgesic Gel
View Indications, Usage & Precautions
Xtracare Ice Cold Topical Analgesic Gel Product Label
The following document was submitted to the FDA by the labeler of this product Rejoice International. 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: Purpose
Menthol 1.25% ........................... Topical Analgesic
Otc - Purpose
Uses
for the temporary relief of minor aches and pains of muscles and joints.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
Indications & Usage
XtraCare® Ice Cold Topical Analgesic Gel
Net Wt 8 oz (227 g)
Warnings
Warnings
For external use only. Avoid contact with eyes.
Ask a doctor before use if you have cough associated with
- smoking
- excessive phlegm
- asthma
- emphysema
- persistent or chronic cough
- heat
- microwave
- add to hot water or any container where heating water may cause splattering and result in burns
- use in eyes or directly on mucous membranes
- take by mouth or place in nostrils
- apply to wounds or damaged skin
- bandage skin
When using this product do not
Consult a doctor and discontinue use if condition worsens, persists for more than 1 week or tends to recur.
Dosage & Administration
Directions
- see important warnings under "When using this product"
- adults & children 2 years of age & older: apply to the affected area not more than 3 to 4 times daily.
- children under 2 years of age: consult a physician
Inactive Ingredient
Inactive Ingredients:
camphor, carbomer, ethyl alcohol, FD&C blue no.1, isopropyl alcohol, methylchloroisothiazolinone, methylisothiazolinone, sodium hydroxide, water.
Other Safety Information
Other information: store at 20o to 25oC (68o to 77oF)
Questions/Comments? 1-855-345-5575
DISTRIBUTED BY:
REJOICE INTERNATIONAL INC
NORTHVILLE, MI 48168 USA
MADE IN CHINA
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