Active Ingredient
Camphor 0.5%
Calmara Lotion
FDA Label NDC 67777-017
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dynarex Corporation for the product Calmara (NDC 67777-017). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, when using this product, stop use and ask a doctor if, otc - pregnancy or breast feeding, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
1200_in_master (1200 In Master R251126 6)
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