Drugplain

Calamine Phenolated Topical Suspension 10 mg/mL

Calamine and Zinc Oxide and Phenol · LOTION · Pharma Nobis, LLC

No Recall History
Plain English

Calamine Phenolated is a topical lotion applied directly to the skin to help relieve itching and discomfort from minor skin irritations such as insect bites, poison ivy, and eczema. It contains calamine, zinc oxide, and phenol, which work together to soothe irritated skin.

Key Facts

Brand Name
Calamine Phenolated Topical Suspension
Generic Name
Calamine and Zinc Oxide and Phenol
NDC Code (Product)
82645-921
Manufacturer
Pharma Nobis, LLC
Strength
10 mg/mL
Dosage Form
LOTION
Route
TOPICAL
Marketing Status
Application #
M016
Marketing Start
01/01/2008

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

diabetes mellitus1 reports
drug reaction with eosinophilia and systemic symptoms1 reports
drug-induced liver injury1 reports
gastroenteritis1 reports
hepatic function abnormal1 reports
herpes zoster1 reports
injection site pruritus1 reports
injection site rash1 reports
musculoskeletal stiffness1 reports
off label use1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses Dries the oozing and weeping and temporarily pain and itching of poison ivy, poison oak, and poison sumac, or other minor skin irritations

Dosage & Administration

directions (Shake well before using) Adult and children 2 years of age and older: Cleanse the skin with soap and water and let dry before each use. Apply product to the affected area using cotton or soft cloth, as often as needed for comfort. Children under 2 years of age : Consult a doctor before use.

Warnings

Warnings For external use only . Use only as directed. Avoid contact with eyes and mucous membranes. Do not apply to large areas of the body or in large quantities, particularly over raw or blistered areas. If applied to fingers or toes do not bandage.

Frequently Asked Questions

What is Calamine Phenolated Topical Suspension used for?

Calamine Phenolated is a topical lotion applied directly to the skin to help relieve itching and discomfort from minor skin irritations such as insect bites, poison ivy, and eczema. It contains calamine, zinc oxide, and phenol, which work together to soothe irritated skin.

Is Calamine Phenolated Topical Suspension a controlled substance?

Calamine Phenolated Topical Suspension is not classified as a controlled substance by the DEA.

What is the generic name for Calamine Phenolated Topical Suspension?

The generic name for Calamine Phenolated Topical Suspension is Calamine and Zinc Oxide and Phenol. There are 2 other brand versions of Calamine and Zinc Oxide and Phenol.

What is the NDC code for Calamine Phenolated Topical Suspension 10 mg/mL?

The NDC (National Drug Code) for Calamine Phenolated Topical Suspension 10 mg/mL is 82645-921, listed by Pharma Nobis, LLC.

Product NDC

82645-921

Package NDC

82645-921-96

Other Calamine Phenolated Topical Suspension Dosages

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)