FDA.reportPublic FDA data

Calamine

Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2024-06-06
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:14:45

Label at a glance#

ProductCalamine
Active ingredientFERRIC OXIDE RED, ZINC OXIDE
Label structure13 sections

Dosage and administration

• shake well before using • apply as needed

Storage and handling

store at 59⁰ - 86⁰ F

Label contents#

Full prescribing information#

Active ingredents

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:•ivy • 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 - 86⁰ F

Inactive ingredients

INACTIVE INGREDIENT SECTION

bentonite magma, calcium hydroxide, glycerin, purified water

Questions or comments?

OTC - QUESTIONS SECTION

(800) 616-2471

Adverse reactions

ADVERSE REACTIONS SECTION

Distributed By:

MAJOR PHARMACEUTICALS

17177 N LAUREL PARK DRIVE, SUITE 233

Livonia, MI 48152

Re-Order No 014282  M-97

Rev. 10/16

063.000/063AA

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pdppdp

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
617954calamine 8 % / zinc oxide 8 % Topical LotionPSN5
617954calamine 80 MG/ML / zinc oxide 80 MG/ML Topical LotionSCD5
617954calamine 8 % / zinc oxide 8 % Topical LotionSY5
617954Calamine 80 MG/ML / ZNO 80 MG/ML Topical LotionSY5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-4322-62023-07-03C16284748780-1ba0f9c33-3aec-a910-e053-dadaa90a0b85Drug Facts
68071-4322-62023-01-30C16284748780-1ba0f9c33-3aec-a910-e053-dadaa90a0b85Drug Facts
68071-4322-62021-03-02C16284748780-1ba0f9c33-3aec-a910-e053-dadaa90a0b85Drug Facts
68071-4322-62021-01-29C16284748780-1ba0f9c33-3aec-a910-e053-dadaa90a0b85Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4322-6Calamine177 mL in 1 BOTTLELOTION1775

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4322CALAMINE (FERRIC OXIDE RED) LOTION [NUCARE PHARMACEUTICALS,INC.]5Current NDC, Legacy NDC, 1 package rows20240706_66e98554-e158-a519-e053-2a91aa0a6783.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-2533-21ML - Milliliter0904-2533918d193f-eb73-474a-b375-ecfe47fd756e12014-10-03

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68071-432268071-4322-6
0904-2533

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
BENTONITEA3N5ZCN45CIACT
CALCIUM HYDROXIDEPF5DZW74VNIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
FERRIC OXIDE RED1K09F3G675ACTIB
ZINC OXIDESOI2LOH54ZACTIB

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CalamineFERRIC OXIDE REDMajor Pharmaceuticalsc25be68d-834a-4959-8d47-01ec789406ba2026-02-04Warnings, Adverse reactionsExact identifier
ndc (product): 0904-2533
CalamineFERRIC OXIDE REDNuCare Pharmaceuticals,Inc.66e98554-e158-a519-e053-2a91aa0a67832024-06-06Warnings, Adverse reactionsExact identifier
ndc (package): 68071-4322-6
ndc (product): 68071-4322
ndc11 (package): 68071432206
spl id: 1a3dc619-6b13-21b4-e063-6294a90acb1e
spl set id: 66e98554-e158-a519-e053-2a91aa0a6783

Reported adverse events (FAERS/openFDA)#

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