Drugplain

Calamine Plus 5 mg/g

Calamine Plus Pramoxine HCL · AEROSOL, SPRAY · Chain Drug Marketing Association Inc

No Recall History
Plain English

Calamine Plus is a topical spray containing calamine and pramoxine that you can buy without a prescription to help relieve itching and discomfort from insect bites, minor skin irritations, and rashes. You apply it directly to the affected skin area for temporary relief.

Key Facts

Brand Name
Calamine Plus
Generic Name
Calamine Plus Pramoxine HCL
NDC Code (Product)
83324-242
Manufacturer
Chain Drug Marketing Association Inc
Strength
5 mg/g
Dosage Form
AEROSOL, SPRAY
Route
TOPICAL
Marketing Status
Application #
M017
Marketing Start
06/07/2024

Recall History

No Recall History

Side Effects Reported to FDA

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

drug ineffective506 reports
macular degeneration453 reports
off label use313 reports
pyrexia303 reports
nausea284 reports
pain280 reports
malaise259 reports
weight decreased235 reports
therapeutic product effect incomplete213 reports
headache201 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporarily relieves pain and itching associated with: insect bites rashes minor skin irritations minor cuts dries the oozing and weeping of poison ivy, poison oak and poison sumac

Dosage & Administration

Directions shake well before using adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily cleanse the skin with soap and water let dry before use children under 2 years of age: consult a doctor Other Information store between 20° to 25°C (68° to 77°F)

Warnings

Warnings For external use only. Flammable: Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal. When using this product do not get into eyes ask a doctor before using on children under 2 years of age Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again in a few days Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Frequently Asked Questions

What is Calamine Plus used for?

Calamine Plus is a topical spray containing calamine and pramoxine that you can buy without a prescription to help relieve itching and discomfort from insect bites, minor skin irritations, and rashes. You apply it directly to the affected skin area for temporary relief.

Is Calamine Plus a controlled substance?

Calamine Plus is not classified as a controlled substance by the DEA.

What is the generic name for Calamine Plus?

The generic name for Calamine Plus is Calamine Plus Pramoxine HCL. There are no other listed brand versions of Calamine Plus Pramoxine HCL.

What is the NDC code for Calamine Plus 5 mg/g?

The NDC (National Drug Code) for Calamine Plus 5 mg/g is 83324-242, listed by Chain Drug Marketing Association Inc.

Product NDC

83324-242

Package NDC

83324-242-41

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

Data from openFDA · Public domain (CC0 1.0)