FDA.reportPublic FDA data

Private Label Calamine Lotion

Manufacturer
Pharma Nobis, LLC
Effective date
2023-12-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:05:32

Label at a glance#

ProductCalamine
Active ingredientZINC OXIDE
Label structure26 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 2 years of age: Consult a doctor before use Children under 2 years of age: Consult a doctor before use (12/2021)

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 2 years of age: Consult a doctor before use

Directions

RECENT MAJOR CHANGES SECTION

Children under 2 years of age: Consult a doctor before use (12/2021)

Other information

OTHER SAFETY INFORMATION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Bentonite magma, calcium hydroxide, glycerin, purified water.

Good Neighbor Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GNPCal.jpgGNPCal.jpg

Health Care Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HCHC

Quality Choice Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

QCCal.jpgQCCal.jpg

Select Brand Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SBSB

Sun Mark Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SMCal.jpgSMCal.jpg

Premier Value

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PVCal.jpgPVCal.jpg

Fred's Calamine

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FredsFreds

DDM Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DDMDDM

Rite Aid Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RACal.jpgRACal.jpg

Harris Teeter Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HTHT

Health Mart Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HMCal.jpgHMCal.jpg

Dollar Tree Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DollarDollar

Equate Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Equate CalamineEquate CalamineEquateEquate

99 Cent Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

99Cal.jpg99Cal.jpg

Top Care Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Top Care CalamineTop Care CalamineTCCal.jpgTCCal.jpg

Assured Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AssuredCal.jpgAssuredCal.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
617954calamine 8 % / zinc oxide 8 % Topical LotionPSN2
617954calamine 80 MG/ML / zinc oxide 80 MG/ML Topical LotionSCD2
617954calamine 8 % / zinc oxide 8 % Topical LotionSY2
617954Calamine 80 MG/ML / ZNO 80 MG/ML Topical LotionSY2

DailyMed Pharmacologic Classes#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82645-900-96Calamine177 mL in 1 BOTTLE, PLASTICLOTION1772

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82645-900CALAMINE (CALAMINE 8% AND ZINC OXIDE 8%) LOTION [PHARMA NOBIS, LLC]2Current NDC, Legacy NDC, 1 package rows20231223_e42f0bd6-3ad3-7e07-e053-2995a90a564a.zip

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
82645-90082645-900-96

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
CARRAGEENAN5C69YCD2YJIACT
XANTHAN GUMTTV12P4NEEIACT
CALCIUM HYDROXIDEPF5DZW74VNIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
BENTONITEA3N5ZCN45CIACT
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
CalamineCALAMINE 8% AND ZINC OXIDE 8%Pharma Nobis, LLCe42f0bd6-3ad3-7e07-e053-2995a90a564a2023-12-22WarningsExact identifier
ndc (package): 82645-900-96
ndc (product): 82645-900
ndc11 (package): 82645090096
spl id: 0d1cd55e-cd93-6e7e-e063-6294a90ae7a5
spl set id: e42f0bd6-3ad3-7e07-e053-2995a90a564a

Reported adverse events (FAERS/openFDA)#

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