FDA.reportPublic FDA data

CVS Calamine Plus

Manufacturer
CVS Pharmacy | Pharma Nobis, LLC
Effective date
2023-12-22
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:05:31

Label at a glance#

ProductCVS Calamine Plus
Active ingredientZINC OXIDE, PRAMOXINE HYDROCHLORIDE
Label structure11 sections

Dosage and administration

Adults and children 2 yrs. o f age and older . Shake well before using. Cleanse the skin with soap and water and let dry. Apply to the affected area using cotton or soft cloth not more than 3 to 4 times daily as needed for comfort. Children under 2 yrs. of age: Consult a doctor.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

CVS Calamine Plus

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Calamine 8%

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Pramoxine HCl 1%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Purpose

OTC - PURPOSE SECTION

External Analgesic

Use

INDICATIONS & USAGE SECTION

Dries the oozing and weeping, and temporarily relieves pain and itching of poison ivy, oak, and sumac or other minor skin irritations.

Warnings

WARNINGS SECTION

For external use only. Use only as directed.

When using this product avoid contact with eyes.

OTC - WHEN USING SECTION

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms last for 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

  • In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 2 yrs. of age and older. Shake well before using. Cleanse the skin with soap and water and let dry. Apply to the affected area using cotton or soft cloth not more than 3 to 4 times daily as needed for comfort.
  • Children under 2 yrs. of age: Consult a doctor.

Other Information

OTHER SAFETY INFORMATION

  • store at room temperature 15 o – 30 oC (59 o – 85 oF)

Inactive Ingredient

INACTIVE INGREDIENT SECTION

SD Alcohol 38B 2.5%, Camphor, Diazolidinyl Urea, Fragrances, Glycerin, Hypromellose, Methylparaben, Polysorbate 80, Propylene Glycol, Propylparaben, and Purified Water.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Calamine
Plus
Itch Relief
6 FL OZ (177 mL)

PRINCIPAL DISPLAY PANEL Calamine Plus Itch Relief 6 FL OZ (177 mL)PRINCIPAL DISPLAY PANEL Calamine Plus Itch Relief 6 FL OZ (177 mL)

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
69842-420-96CVS Calamine Plus177 mL in 1 BOTTLE, PLASTICLOTION1775

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-420CVS CALAMINE PLUS (ZINC OXIDE) LOTION [CVS PHARMACY]5Current NDC, Legacy NDC, 1 package rows20231223_b90cd214-d44a-4458-876d-59cc0795226d.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-42069842-420-96

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
GLYCERINPDC6A3C0OXIACT
HYPROMELLOSES3NXW29V3WOIACT
METHYLPARABENA2I8C7HI9TIACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
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
CVS Calamine PlusZINC OXIDECVS Pharmacyb90cd214-d44a-4458-876d-59cc0795226d2023-12-22WarningsExact identifier
ndc (package): 69842-420-96
ndc (product): 69842-420
ndc11 (package): 69842042096
spl id: 0d19a0a5-ed0b-1796-e063-6294a90a7e8f
spl set id: b90cd214-d44a-4458-876d-59cc0795226d

Reported adverse events (FAERS/openFDA)#

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