Harris Teeter Calamine Lotion

Manufacturer
Harris Teeter, LLC. | Pharma Nobis, LLC
Effective date
2023-12-20
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:05:10

Label at a glance#

ProductHarris Teeter Calamine
Active ingredientZINC OXIDE
Label structure12 sections

Indications and uses

Dries the oozing and weeping of poison ivy, poison oak, and poison sumac.

Dosage and administration

Adults and children 2 yrs. 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 or soft cloth, as often as needed. Children under 6 months of age: Consult a doctor before use.

Label contents#

Full prescribing information#

Harris Teeter Calamine Lotion

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Calamine 8%

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 8%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

Dries the oozing and weeping of 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, does not improve or if symptoms persist for more than 7 days, or clear up and occur again within a few 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 yrs. 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 or soft cloth, as often as needed.
  • Children under 6 months of age: Consult a doctor before use.

Other Information

OTHER SAFETY INFORMATION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Avicel, Bentonite Magma, Calcium Hydroxide, Carrageenan, Glycerin, Purified Water, and Xanthan Gum.

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

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

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69256-413-96Harris Teeter Calamine177 mL in 1 BOTTLE, PLASTICLIQUID1775

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69256-413HARRIS TEETER CALAMINE (ZINC OXIDE) LIQUID [HARRIS TEETER, LLC.]5Current NDC, Legacy NDC, 1 package rows20231221_86021cc5-fea7-4363-8fb2-2b0484437fe8.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69256-41369256-413-96

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

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
Harris Teeter CalamineZINC OXIDEHarris Teeter, LLC.86021cc5-fea7-4363-8fb2-2b0484437fe82023-12-20WarningsExact identifier
ndc (package): 69256-413-96
ndc (product): 69256-413
ndc11 (package): 69256041396
spl id: 0cf50e80-8b01-ed5f-e063-6394a90a8275
spl set id: 86021cc5-fea7-4363-8fb2-2b0484437fe8

Reported adverse events (FAERS/openFDA)#

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