Calaclear
Calaclear is an FDA drug label for the active ingredient PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE manufactured by Pharma Nobis, LLC administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231226.
Generic: PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE
Manufacturer: Pharma Nobis, LLC
Product Type: HUMAN OTC DRUG
Route: TOPICAL
Dosage Form:
NDC: 82645-923
Application: M016
Effective: 20231226
Active Ingredients: Active Ingredient Pramoxine HCl 1%Active Ingredient Zinc Acetate 0.1%
Indications & Usage
Use Dries the oozing and weeping and temporarily relieves pain and itching of poison ivy, poison oak, and poison sumac or other minor skin irritations.
Dosage & Administration
Directions Adults and children 2 yrs. 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: Consult a doctor before use.
Contraindications
Not available.
Warnings
Warnings For external use only. Use only as directed. Avoid contact with eyes and mucous membranes. Ask a doctor before using on children under 2 years of age. When using this product . Discontinue use if condition worsens, does not improve or if symptoms persist for more than 7 days, or clear up and occur again within a few days. and consult a doctor. Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
Adverse Reactions
Not available.