Calamine 80 mg/mL
Calamine 8%, Zinc Oxide 8% · LOTION · Farmacias De Similares TX LLC
Calamine is a lotion containing calamine 8%, zinc oxide 8% at 80 mg/mL, taken topical. Manufactured by Farmacias De Similares TX LLC.
Key Facts
- Brand Name
- Calamine
- Generic Name
- Calamine 8%, Zinc Oxide 8%
- NDC Code (Product)
85786-703- Manufacturer
- Farmacias De Similares TX LLC
- Strength
- 80 mg/mL
- Dosage Form
- LOTION
- Route
- TOPICAL
- Marketing Status
- Application #
- M016
- Marketing Start
- 04/06/2026
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 8%, Zinc Oxide 8%. 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 8%, Zinc Oxide 8%. There are no other listed brand versions of Calamine 8%, Zinc Oxide 8%.
What is the NDC code for Calamine 80 mg/mL?
The NDC (National Drug Code) for Calamine 80 mg/mL is 85786-703, listed by Farmacias De Similares TX LLC.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)