FDA.reportPublic FDA data

Swan 063.001/063AA Calamine Lotion

Manufacturer
Nice-Pak Products, LLC
Effective date
2026-09-15
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
daily-update
Hydrated at
2026-09-17 01:00:49

Label at a glance#

ProductCalamine
Active ingredientFERRIC OXIDE RED, ZINC OXIDE
Label structure12 sections

Dosage and administration

shake well before using apply as needed

Storage and handling

store at 59⁰ - 86⁰F

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Calamine 8%

Zinc oxide 8%

Purpose

OTC - PURPOSE SECTION

Skin protectant

Use

INDICATIONS & USAGE SECTION

dries the oozing and weeping of poison:•i vy • oak • sumac

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

Do not get into eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well before using
  • apply as needed

Other information

STORAGE AND HANDLING SECTION

store at 59⁰ - 86⁰F

Inactive ingredients

INACTIVE INGREDIENT SECTION

bentonite magma, calcium hydroxide, glycerin, purified water

Adverse reaction

ADVERSE REACTIONS SECTION

Distributed by:

Consumer Product Partners, LLC,

St. Louis, MO 63114

1-888-593-0593

Principal Panel Display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SWAN ®

Calamine Lotion

  • Calamine topical Suspension USP
  • Skin Protectant
  • Poison Ivy, Oak, Sumac Drying Lotion

6 FL OZ (177 mL)

image descriptionimage description

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
11344-06311344-063-30

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
ZINC OXIDESOI2LOH54ZACTIB
BENTONITEA3N5ZCN45CIACT
CALCIUM HYDROXIDEPF5DZW74VNIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32026-03-12full-release2026-06-01 01:50:13

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
4cd60a24-bce7-f425-e063-6294a90a628bc370ee1f-1887-44e8-8d47-8ffa3c270ff52026-03-12Warnings, Adverse reactionsExact identifier
spl set id: c370ee1f-1887-44e8-8d47-8ffa3c270ff5

Reported adverse events (FAERS/openFDA)#

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