FDA Label for Calmara
View Indications, Usage & Precautions
Calmara Product Label
The following document was submitted to the FDA by the labeler of this product Dynarex 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.
Active Ingredient
Camphor 0.5%
Purpose
External Analgesic
Uses
For temporary relief of pain and itching associated with
• minor burns
• minor cuts
• insect bites
• sunburn
• scrapes
• minor skin irritations
Warnings
For external use only
When Using This Product
• Avoid contact with the eyes
Stop Use And Ask A Doctor If
• condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.
Otc - Pregnancy Or Breast Feeding
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) right away.
Directions
• Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: do not use, consult a doctor.
Other Information
• Store at room temperature 15°-30°C (59°-86°F)
• Avoid excessive heat
• Tamper evident. Do not use if seal is damaged.
Inactive Ingredients
carbomer, cetearyl alcohol, dimethicone, disodium EDTA, glycol stearate, imidazolidinyl urea, menthol, methylparaben, mineral oil, PEG-4 dilaurate, PEG-40 castor oil, petrolatum, propylene glycol, propylparaben, sodium cetearyl sulfate, stearic acid, titanium dioxide, triethanolamine, water
Questions?
1-888-DYNAREX Monday-Friday, 9AM-5PM EST
Label
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