FDA.reportPublic FDA data

Fred's Calamine Lotion

Manufacturer
Fred's, Inc. | Pharma Nobis, LLC
Effective date
2022-03-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:05:48

Label at a glance#

ProductFreds Calamine
Active ingredientZINC OXIDE
Label structure11 sections

Indications and uses

dries the oozing and weeping o poison ivy, poison oak, and poison sumac.

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#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Calamine 8% and Zinc Oxide 8%

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

dries the oozing and weeping o poison ivy, poison oak, and poison sumac.

Warnings

WARNINGS SECTION

For external use only. Use only as directed.

Avoid contact with eyes and mucous membranes.

Ask a doctor before using on chilren 6 months of age.

When using this product

OTC - WHEN USING SECTION

Discontinue use if condition worsens or does not improve within 7 days and consult a doctor.

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.

Other information

OTHER SAFETY INFORMATION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Avicel, bentonite magma, calcium hydroxide, carrageenan, glycerin, purified water, and xanthan gum.

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55315-41355315-413-96

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
XANTHAN GUMTTV12P4NEEIACT
CARRAGEENAN5C69YCD2YJIACT
BENTONITEA3N5ZCN45CIACT
CALCIUM HYDROXIDEPF5DZW74VNIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
ZINC OXIDESOI2LOH54ZACTIM

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
da6acc7d-6950-8bd1-e053-2a95a90a3fb05df48f74-ea90-9a01-e053-2a91aa0a7d3b2022-03-17WarningsExact identifier
spl id: da6acc7d-6950-8bd1-e053-2a95a90a3fb0
spl set id: 5df48f74-ea90-9a01-e053-2a91aa0a7d3b

Reported adverse events (FAERS/openFDA)#

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