FDA.reportPublic FDA data

Pure Calamine Lotion 19%

Manufacturer
1201258 Ontario Inc.O/A Nanz Pharma | 1201258 Ontario Inc. O/A Nanz Pharma
Effective date
2023-05-18
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:31:16

Label at a glance#

ProductNanz Pure
Active ingredientFERRIC OXIDE RED, ZINC OXIDE
Label structure10 sections

Indications and uses

For temporary relief of skin irritations and itching caused by sunburn, poison ivy, sumac and poison oak.

Dosage and administration

Adults and children 2 years and older. Shake well before using. Cleanse the skin with soap and water and let dry before each use. Apply lotion to the affected area using cotton or soft cloth, as often as needed for comfort. Children under 6 months of age: consult a doctor before use.

Storage and handling

Store at room temperature 50-86F

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Calamine 19% Zinc Oxide 19%

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses:

INDICATIONS & USAGE SECTION

For temporary relief of skin irritations and itching caused by sunburn, poison ivy, sumac and poison oak.

Caution and Warnings:

WARNINGS SECTION

FOR EXTERNAL USE ONLY. Use only as directed.

When using this product, avoid contact with eyes. I contact occurs, rinse thoroughly with water.

Stop use and as/consult a doctor/physician/healthcare practitioner/healthcare provider/ healthcare professional if symptoms worsen or last for more than 7 days.

Do not use on broken skin.

KEEP OUT OF REACH OF CHILDREN.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, seek professional assistance or contact Poison Control Center immediately.

Directions:

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years and older. Shake well before using. Cleanse the skin with soap and water and let dry before each use. Apply lotion to the affected area using cotton or soft cloth, as often as needed for comfort. Children under 6 months of age: consult a doctor before use.

Other information:

STORAGE AND HANDLING SECTION

Store at room temperature 50-86F

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Glycerin, Bentonite, Calcium hydroxide, water

Distributed by:

SPL UNCLASSIFIED SECTION

1201258 Ontario Inc. Nanz Pharma, 575 Granite Court, Pickering, ON L1W 3K1

Questions or Comments: ###-###-####

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label for all povidone iodine 19 percentLabel for all povidone iodine 19 percentFor all bottle sizes. A tentative Label

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83254-01983254-019-10, 83254-019-50, 83254-019-20, 83254-019-02, 83254-019-05, 83254-019-06, 83254-019-55, 83254-019-01, 83254-019-25, 83254-019-22

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
FERRIC OXIDE RED1K09F3G675ACTIB
BENTONITEA3N5ZCN45CIACT
GLYCERINPDC6A3C0OXIACT
CALCIUM HYDROXIDEPF5DZW74VNIACT
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
1a4f8696-5fed-5759-e063-6394a90a425df49b40e1-2e36-7174-e053-2995a90af1a32024-06-07WarningsExact identifier
spl set id: f49b40e1-2e36-7174-e053-2995a90af1a3

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.