FDA Label for Topcare Calaclear
View Indications, Usage & Precautions
Topcare Calaclear Product Label
The following document was submitted to the FDA by the labeler of this product Topco Associates Llc. 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
Pramoxine HCl 1%
Zing Acetate 0.1%
Otc - Purpose
External Analgesic
Skin Protectant
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.
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.
Dosage & Administration
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.
Inactive Ingredient
SD Alcohol 38B 2.5%, Camphor, Diazolidinyl Urea, Fragrances, Glycerin, Hydroxypropyl Methylcellulose, Methylparaben, Polysorbate 80, Propylene Glycol, Propylparaben, Purified Water.
Otc - Keep Out Of Reach Of Children
In case of accidental ingestion, seek professional assistance or contact a poison control center immediately.
Package Label.Principal Display Panel
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