FDA.reportPublic FDA data

Nanz Relieve Calamine Lotion

Manufacturer
1201258 Ontario Inc. O/A Nanz Pharma
Effective date
2023-05-18
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-01 21:31:16

Label at a glance#

ProductCalamine
Active ingredientFERRIC OXIDE RED, ZINC OXIDE
Label structure9 sections

Indications and uses

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

Dosage and administration

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, as often as needed for comfort. Children under 6 months of age: Consult a doctor before use.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Calamine 7.6% and Zinc Oxide 7.6%

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses:

INDICATIONS & USAGE SECTION

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

Caution & Warnings:

WARNINGS SECTION

For external use only.Keep out of reach of children. If swallowed, call a poison control centre or get medical help right away. Stop use and ask/consult a doctor/physician/health care practitioner/health care provider/health care professional if symptoms worsen or last for more than 7 days.When using this product, avoid contact with eyes. If contact occurs, rinse thoroughly with water.
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 a Poison Control center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

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, as often as needed for comfort.

Children under 6 months of age: Consult a doctor before use.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Glycerin, Bentonite, Calcium Hydroxide, Water

Other information:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Store at room temperature 13-30C (50-86F)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 83254-075

Labels for all sizes Nanz Relieve Calamine Lotion LabelNanz Relieve Calamine Lotion 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
83254-07683254-076-02, 83254-076-05, 83254-076-25, 83254-076-01, 83254-076-15, 83254-076-10, 83254-076-50, 83254-076-00, 83254-076-06

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
GLYCERINPDC6A3C0OXIACT
FERRIC OXIDE RED1K09F3G675ACTIB
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
CALCIUM HYDROXIDEPF5DZW74VNIACT
BENTONITEA3N5ZCN45CIACT

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
1a4f9544-f6f1-6732-e063-6394a90a9dc9f1ecb705-b0cc-b58d-e053-2a95a90a6d0f2024-06-07WarningsExact identifier
spl set id: f1ecb705-b0cc-b58d-e053-2a95a90a6d0f

Reported adverse events (FAERS/openFDA)#

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