Drugplain

Calamine 160 mg/mL

Calamine 8% and Zinc Oxide 8% · LOTION · Pharma Nobis, LLC

1 Recall on Record
Plain English

Calamine lotion is a topical product used to relieve itching and irritation from minor skin conditions such as insect bites, poison ivy, and eczema. It works by cooling the skin and reducing inflammation when applied directly to affected areas.

Key Facts

Brand Name
Calamine
Generic Name
Calamine 8% and Zinc Oxide 8%
NDC Code (Product)
82645-900
Manufacturer
Pharma Nobis, LLC
Strength
160 mg/mL
Dosage Form
LOTION
Route
TOPICAL
Marketing Status
Application #
M016
Marketing Start
03/25/1998

Recall History

1 Recall on Record
Class II06/23/2022

Family Dollar Stores, Llc.

CGMP Deviations: product held outside appropriate storage temperature conditions.

OngoingVoluntary: Firm initiated

Side Effects Reported to FDA

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

drug ineffective536 reports
macular degeneration453 reports
off label use343 reports
pyrexia322 reports
nausea321 reports
pain297 reports
malaise272 reports
weight decreased262 reports
constipation235 reports
headache232 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 used for?

Calamine lotion is a topical product used to relieve itching and irritation from minor skin conditions such as insect bites, poison ivy, and eczema. It works by cooling the skin and reducing inflammation when applied directly to affected areas.

Is Calamine a controlled substance?

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

What is the generic name for Calamine?

The generic name for Calamine is Calamine 8% and Zinc Oxide 8%. There are 11 other brand versions of Calamine 8% and Zinc Oxide 8%.

What is the NDC code for Calamine 160 mg/mL?

The NDC (National Drug Code) for Calamine 160 mg/mL is 82645-900, listed by Pharma Nobis, LLC.

Product NDC

82645-900

Package NDC

82645-900-96

Other Calamine Brands

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

Data from openFDA · Public domain (CC0 1.0)