Calamine 80 mg/mL
Calamine, Pramoxind HCl · LOTION · Nice-Pak Products, LLC
Calamine is a lotion containing calamine, pramoxind hcl at 80 mg/mL, taken topical. Manufactured by Nice-Pak Products, LLC.
Key Facts
- Brand Name
- Calamine
- Generic Name
- Calamine, Pramoxind HCl
- NDC Code (Product)
11344-136- Manufacturer
- Nice-Pak Products, LLC
- Strength
- 80 mg/mL
- Dosage Form
- LOTION
- Route
- TOPICAL
- Marketing Status
- Application #
- M016
- Marketing Start
- 09/08/2016
Recall History
Family Dollar Stores, Llc.
CGMP Deviations: product held outside appropriate storage temperature conditions.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
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 contains Calamine, Pramoxind HCl. It is a lotion taken topical. Consult your doctor for specific uses.
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, Pramoxind HCl. There are no other listed brand versions of Calamine, Pramoxind HCl.
What is the NDC code for Calamine 80 mg/mL?
The NDC (National Drug Code) for Calamine 80 mg/mL is 11344-136, listed by Nice-Pak Products, LLC.
Other Calamine Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)