FDA.reportPublic FDA data

Leader Calamine Plus

Manufacturer
Cardinal Health, 110 dba Leader
Effective date
2023-12-22
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:05:29

Label at a glance#

ProductLeader Calamine Plus
Active ingredientZINC OXIDE, PRAMOXINE HYDROCHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

WARNINGS SECTION

  • For external use only
  • Avoid contact with eyes and mucous membranes
  • Ask a doctor before using on children under 2 years of age

OTC - ACTIVE INGREDIENT SECTION

Calamine 8%

Pramoxine HCl 1%

OTC - PURPOSE SECTION

  • Skin Protectant
  • External Analgesic

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 of soft cloth, not more than 3 to 4 times daily as needed for comfort.

Children under 2 years of age: Consult a doctor before use.

INACTIVE INGREDIENT SECTION

SH Alcohol 38B 2.5%

Camphor

Diazolidinyl Urea

Fragrances

Glycerin

Hydroxypropyl Methylcellulose

Methylparaben

Polysorbate 80

Propylene Glycol

Propylparabaren

Purified water

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222)

INDICATIONS & USAGE SECTION

Uses:
temporarily relieves pain and itching associated with:

  • rashes due to poison ivy, poison oak, or poison sumac
  • insect bites
  • minor skin irritation
  • minor cuts
  • ​dries the oozing and weeping of poison ivy, poison oak and poison sumac

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

calaminepluscalamineplus

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1234532calamine 8 % / pramoxine HCl 1 % Topical LotionPSN5
1234532calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical LotionSCD5
1234532calamine 8 % / pramoxine hydrochloride 1 % Topical LotionSY5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0400-1Leader Calamine Plus177 mL in 1 CONTAINERLOTION1775

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0400LEADER CALAMINE PLUS (ZINC OXIDE LOTION) LOTION [CARDINAL HEALTH, 110 DBA LEADER]5Current NDC, Legacy NDC, 1 package rows20231223_81f29789-f794-1e64-e053-2a91aa0ac85e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0400-1ML - Milliliter70000-040002eb5c5d-1078-4172-acc3-41965dc92c4e12019-08-06

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-040070000-0400-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
HYPROMELLOSES3NXW29V3WOIACT
GLYCERINPDC6A3C0OXIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
POLYSORBATE 806OZP39ZG8HIACT
WATER059QF0KO0RIACT
ZINC OXIDESOI2LOH54ZACTIM
PRAMOXINE HYDROCHLORIDE88AYB867L5ACTIB

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
Leader Calamine PlusZINC OXIDE LOTIONCardinal Health, 110 dba Leader81f29789-f794-1e64-e053-2a91aa0ac85e2023-12-22WarningsExact identifier
ndc (package): 70000-0400-1
ndc (product): 70000-0400
ndc11 (package): 70000040001
spl id: 0d1994b2-3c1b-6322-e063-6394a90a1b6c
spl set id: 81f29789-f794-1e64-e053-2a91aa0ac85e

Reported adverse events (FAERS/openFDA)#

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