Drug Facts Active Ingredient
Calamine 8%
Zinc Oxide 8%
Calamine Lotion
FDA Label NDC 85786-703
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Farmacias De Similares Tx Llc for the product Calamine (NDC 85786-703). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts active ingredient, purpose, uses, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Calamine 8%, Zinc Oxide 8% | Skin protectant |
Uses
Dries the oozing and weeping of poison:
■ ivy
■ oak
■ sumac
Warnings
■ For external use only
■ Use only as directed
When Using This Product
■ do not get into eyes
Stop Use And Ask A Doctor If
■ condition worsens
■ symptoms last more than 7 days or clear up and occur again within a few days
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
■ Adults and children of 2 years of age and older: Shake well before using. Cleanse the skin with soap and water and dry the area before application. Apply lotion 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.
Other Information
Store at room temperature 15° - 30°C (59° - 86°F)
Inactive Ingredients
Avicel, bentonite magma, calcium hydroxide, carrageenan, glycerin, purified water, and xanthan gum.
Questions Or Comments?
(855)-280-1079
Principal Display Panel
NDC: 85786-703-06
DR. SIMI
Calamine Lotion
Calamine
Topical Suspension
Skin Protectant
Poison Ivy, Oak, and Sumac Drying Lotion
6 fl oz (177 mL)
WARNING: DO NOT USE IF TAMPER EVIDENT SEAL UNDER CAP IS BROKEN OR MISSING.
Distributed by:
FARMACIAS DE SIMILARES TX LLC
800 Brazos St Ste 260, Austin, TX, 78701, USA
[email protected]
www.drsimi.com
* Please review the disclaimer below.
