Calamine Lotion
FDA Label NDC 82645-418

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pharma Nobis, Llc for the product Calamine (NDC 82645-418). 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 other, active ingredients, uses, purpose, warnings, 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

Other

Drug Facts

Active Ingredients

Calamine 8% and Zinc Oxide 8%

Uses

Dries the oozing and weeping of poison ivy, poison oak, and poison sumac.

Purpose

Skin protectant

Warnings

For external use only. Use only as directed.

Avoid contact with eyes and mucous membranes.

Ask a doctor before using on chilren under 2 years of age.

Stop Use And Ask A Doctor If

condition worsens, does not improve or if 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 accidental ingestion, seek professional assistance or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Adults and chidren 2 years of age and older: shake well before using. Cleanse the skin with soap and water and let it dry befroe each use. Apply lotion to the affected area using a cotton or soft cloth, not more than 3 to 4 times daily as needed for comfort.

Children under 2 years of age: Consult a doctor before use

Other Information

Store at room temperature 15-30C (59-86F)

Inactive Ingredients

Avicel, Bentonite Magma, Calcium Hydroxide, Glycerin, Purified Water, and Xanthan Gum

* Please review the disclaimer below.