FDA.reportPublic FDA data

Humco Calamine Lotion

Manufacturer
Humco holding Group, Inc. | Pharma Nobis, LLC
Effective date
2026-05-26
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:59:04

Label at a glance#

ProductHumco Calamine
Active ingredientZINC OXIDE
Label structure12 sections

Indications and uses

dries the oozing and weeping o poison ivy, poison oak, and poison sumac.

Dosage and administration

Adults and children 2 years of age and older: shake well before using. Cleanse the skin with soap and water and dry the area before application. Apply lotion to the affected area using cotton or soft cloth, as often as needed for comfort. Children under 2 years of age: Consult a doctor before use.

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.

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 children 2 years of age and older: shake well before using. Cleanse the skin with soap and water and dry the area before application. Apply lotion to the affected area using cotton or soft cloth, as often as needed for comfort.

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

Other information

OTHER SAFETY INFORMATION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Bentonite magma, calcium hydroxide, carrageenan, glycerin, microcrystalline cellulose, purified water, and xanthan gum.

2026 Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Humco Calamine 2026Humco Calamine 2026

Package Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

99Cent.jpg99Cent.jpgcapture.jpgcapture.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
617954calamine 8 % / zinc oxide 8 % Topical LotionPSN8
617954calamine 80 MG/ML / zinc oxide 80 MG/ML Topical LotionSCD8
617954calamine 8 % / zinc oxide 8 % Topical LotionSY8
617954Calamine 80 MG/ML / ZNO 80 MG/ML Topical LotionSY8

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130303950413969GTIN-13: 0303950413969
EAN-13: 0303950413969
GTIN-12: 303950413969
UPC-A: 303950413969
GTIN storage (14 digits): 00303950413969		Humco Calamine 5 26 2026.jpg, capture.jpg
QR code linkQR Codewww.simplehomeremedies.com/products/calamine-lotion.phpcapture.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0395-0413-96Humco Calamine177 mL in 1 BOTTLE, PLASTICLOTION1778

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0395-0413-96ML - Milliliter0395-04137388d9e7-558f-47b8-9386-b0372be86ab312014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Zinc OxideACTIVE INGREDIENTSOI2LOH54Z1
ZINC CATIONACTIVE MOIETY13S1S8SF371
CALCIUM HYDROXIDEINACTIVE INGREDIENTPF5DZW74VN1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
WATERINACTIVE INGREDIENT059QF0KO0R1

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
0395-04130395-0413-96

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
BENTONITEA3N5ZCN45CIACT
CARRAGEENAN5C69YCD2YJIACT
XANTHAN GUMTTV12P4NEEIACT
CALCIUM HYDROXIDEPF5DZW74VNIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
ZINC OXIDESOI2LOH54ZACTIM

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 10 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CALCIUM HYDROXIDECALCIUM HYDROXIDEPF5DZW74VNCAPSULE, EXTENDED RELEASE / ORAL14 mgExact identifier — unii candidate
8 equally ranked IID candidates
CALCIUM HYDROXIDECALCIUM HYDROXIDEPF5DZW74VNINJECTION / INTRAVENOUS3.7 mgExact identifier — unii candidate
8 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CALCIUM HYDROXIDECALCIUM HYDROXIDEPF5DZW74VNSUSPENSION / ORALADJ PHExact identifier — unii candidate
8 equally ranked IID candidates
CALCIUM HYDROXIDECALCIUM HYDROXIDEPF5DZW74VNSUSPENSION / ORALADJ PHExact identifier — unii candidate
8 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CALCIUM HYDROXIDECALCIUM HYDROXIDEPF5DZW74VNINJECTION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
8 equally ranked IID candidates
CALCIUM HYDROXIDECALCIUM HYDROXIDEPF5DZW74VNINJECTION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
8 equally ranked IID candidates
CALCIUM HYDROXIDECALCIUM HYDROXIDEPF5DZW74VNCAPSULE, EXTENDED RELEASE / ORAL14 mgExact identifier — unii candidate
8 equally ranked IID candidates
CALCIUM HYDROXIDECALCIUM HYDROXIDEPF5DZW74VNINJECTION / INTRAVENOUS3.7 mgExact identifier — unii candidate
8 equally ranked IID candidates

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
Humco CalamineCALAMINE 8% AND ZINC OXIDE 8%Humco holding Group, Inc.f7dcd959-fb98-43bb-8dd3-a662bf8a053c2026-05-26WarningsExact identifier
ndc (package): 0395-0413-96
ndc (product): 0395-0413
ndc11 (package): 00395041396
spl id: 52b9f60d-7ae7-26c8-e063-6294a90acc20
spl set id: f7dcd959-fb98-43bb-8dd3-a662bf8a053c

Reported adverse events (FAERS/openFDA)#

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