Calananz Lotion, Calalayer Lotion

Manufacturer
1201258 Ontario Inc. O/A Nanz Pharma
Effective date
2023-05-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:31:17

Label at a glance#

ProductCalananz
Active ingredientZINC OXIDE, FERRIC OXIDE RED
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 of age 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. For 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 15%, Zinc Oxide 5%

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. If contact occurs, rinse thoroughly with water.

Stop use and ask/consult a doctor/physician/healthcare pratitioner/ 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 of age 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. For 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

Bentonite, Carboxymethylcellulose Sodium, Fragrance, Glycerin, Isopropyl Alcohol, PEG-40 hydrogenated castor oil, Phenol, Sodium citrate, Water

Distributed by:

SPL UNCLASSIFIED SECTION

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

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

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label for all calamine 15 percentLabel for all calamine 15 percentLabel for all sizes. Tentative design

Products#

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NDC Codes#

Ingredients#

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

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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.

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
1a4f9165-e666-8452-e063-6294a90a4061f4c13db8-a0f8-5713-e053-2995a90a0ae52024-06-07WarningsExact identifier
spl set id: f4c13db8-a0f8-5713-e053-2995a90a0ae5

Reported adverse events (FAERS/openFDA)#

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