Otc - Active Ingredient
Calamine 8%
Pramoxine HCl 1%
Freskaro Calamine Plus Lotion
FDA Label NDC 82645-420
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pharma Nobis, Llc for the product Freskaro Calamine Plus (NDC 82645-420). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, stop use and ask a doctor if, otc - keep out of reach of children, dosage & administration, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
- Skin Protectant
- External Analgesic
Indications & Usage
Dries the oozing and weeping, and temporarily relieves pain and itching of poison ivy, poison oak, and poison sumac or other minor skin irritations.
Warnings
For external use only. Use only as directed.
- Avoid contact with eyes and mucous membranes,
Stop Use And Ask A Doctor If
- condition worsens
- symptoms last more than 7 days, or clear up and occur again within a few days
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 (1-800-222-1222) right away.
Dosage & Administration
Adults and children 2 years of age and older: Shake well before using. Cleanse the skin with soap and water and let dry before each use. Apply lotion to the affected area using cotton or soft cloth, not more than 3 to 4 times daily as needed for comfort.
Children under 2 years of age: do not use, consult a doctor.
Other Information
Store at room temperature 15 - 30C (59 - 86F)
Inactive Ingredient
SH Alcohol 38B 2.5%, Camphor, Diazolidinyl Urea, Fragrances, Glycerin, Hypromellose, Methylparaben, Polysorbate 80, Propylene Glycol, Propylparabaren and Purified water
Questions Or Comments?
1-833-551-0932
* Please review the disclaimer below.
