FDA.reportPublic FDA data

Top Care 063.001/063AA Calamine Lotion

Manufacturer
Topco Associates LLC | Nice-Pak Products, LLC
Effective date
2026-02-13
Label type
HUMAN OTC DRUG LABEL
Version
22
Source
full-release
Hydrated at
2026-06-01 01:44:07

Label at a glance#

ProductCalamine
Active ingredientFERRIC OXIDE RED, ZINC OXIDE
Label structure13 sections

Dosage and administration

shake well before using apply as needed

Storage and handling

store at 59⁰ - 86⁰ F

Label contents#

Full prescribing information#

Active ingredents

OTC - ACTIVE INGREDIENT SECTION

Calamine 8%
Zinc oxide 8%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Use

INDICATIONS & USAGE SECTION

dries the oozing and weeping of poison:

  • ivy 
  • oak 
  • sumac

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

Do not get into eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms last 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

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well before using
  • apply as needed

Other information

STORAGE AND HANDLING SECTION

store at 59⁰ - 86⁰ F

Inactive ingredients

INACTIVE INGREDIENT SECTION

bentonite magma, calcium hydroxide, glycerin, purified water

Questions or comments?

OTC - QUESTIONS SECTION

1-888-423-0139

ADVERSE REACTION

ADVERSE REACTIONS SECTION

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

©TOPCO VIJA0622 QUESTIONS? 1-888-423-0139

topcare@topco.com www.topcarebrand.com

Visit here for more information:

topbrnds.com/4901jk

QUALITY GUARANTEED

principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 36800-063-30

TopCare ®health

Calamine Lotion USP

CALAMINE TOPICAL SUSPENSION USP

SKIN PROTECTANT

Drying Lotion for:

  • Poison Ivy, Oak & Sumac

6 FL OZ (177 mL)

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
617954calamine 8 % / zinc oxide 8 % Topical LotionPSN22
617954calamine 80 MG/ML / zinc oxide 80 MG/ML Topical LotionSCD22
617954calamine 8 % / zinc oxide 8 % Topical LotionSY22
617954Calamine 80 MG/ML / ZNO 80 MG/ML Topical LotionSY22

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-063-26Calamine237 mL in 1 BOTTLE, PLASTICLOTION23722
36800-063-30Calamine177 mL in 1 BOTTLE, PLASTICLOTION17722
36800-063-34Calamine237 mL in 1 BOTTLE, PLASTICLOTION23722

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-063-30ML - Milliliter36800-063ba0277e0-25f2-46b1-b6ce-22e95cb90c9712020-08-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
FERRIC OXIDE REDACTIVE INGREDIENT1K09F3G6751
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z1
FERRIC OXIDE REDACTIVE MOIETY1K09F3G6751
ZINC OXIDEACTIVE MOIETYSOI2LOH54Z1
BENTONITEINACTIVE INGREDIENTA3N5ZCN45C1
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 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-06336800-063-30, 36800-063-26, 36800-063-34

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENTONITEA3N5ZCN45CIACT
CALCIUM HYDROXIDEPF5DZW74VNIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
FERRIC OXIDE RED1K09F3G675ACTIB
ZINC OXIDESOI2LOH54ZACTIB

Source Document#

Source XML

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 · 24 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERINGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CALCIUM HYDROXIDECALCIUM HYDROXIDEPF5DZW74VNINJECTION / INTRAVENOUS3.7 mgExact identifier — unii candidate
16 equally ranked IID candidates
BENTONITEBENTONITEA3N5ZCN45CLOTION / TOPICAL5 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CALCIUM HYDROXIDECALCIUM HYDROXIDEPF5DZW74VNINJECTION / INTRAVENOUS3.7 mgExact identifier — unii candidate
16 equally ranked IID candidates
CALCIUM HYDROXIDECALCIUM HYDROXIDEPF5DZW74VNSUSPENSION / ORALADJ PHExact identifier — unii candidate
16 equally ranked IID candidates
CALCIUM HYDROXIDECALCIUM HYDROXIDEPF5DZW74VNINJECTION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
16 equally ranked IID candidates
CALCIUM HYDROXIDECALCIUM HYDROXIDEPF5DZW74VNCAPSULE, EXTENDED RELEASE / ORAL14 mgExact identifier — unii candidate
16 equally ranked IID candidates
BENTONITEBENTONITEA3N5ZCN45CLOTION / TOPICAL5 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CALCIUM HYDROXIDECALCIUM HYDROXIDEPF5DZW74VNSUSPENSION / ORALADJ PHExact identifier — unii candidate
16 equally ranked IID candidates
CALCIUM HYDROXIDECALCIUM HYDROXIDEPF5DZW74VNINJECTION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
16 equally ranked IID candidates
CALCIUM HYDROXIDECALCIUM HYDROXIDEPF5DZW74VNINJECTION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
16 equally ranked IID candidates
CALCIUM HYDROXIDECALCIUM HYDROXIDEPF5DZW74VNCAPSULE, EXTENDED RELEASE / ORAL14 mgExact identifier — unii candidate
16 equally ranked IID candidates
CALCIUM HYDROXIDECALCIUM HYDROXIDEPF5DZW74VNINJECTION / INTRAVENOUS3.7 mgExact identifier — unii candidate
16 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CALCIUM HYDROXIDECALCIUM HYDROXIDEPF5DZW74VNCAPSULE, EXTENDED RELEASE / ORAL14 mgExact identifier — unii candidate
16 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CALCIUM HYDROXIDECALCIUM HYDROXIDEPF5DZW74VNSUSPENSION / ORALADJ PHExact identifier — unii candidate
16 equally ranked IID candidates
CALCIUM HYDROXIDECALCIUM HYDROXIDEPF5DZW74VNSUSPENSION / ORALADJ PHExact identifier — unii candidate
16 equally ranked IID candidates
CALCIUM HYDROXIDECALCIUM HYDROXIDEPF5DZW74VNCAPSULE, EXTENDED RELEASE / ORAL14 mgExact identifier — unii candidate
16 equally ranked IID candidates
CALCIUM HYDROXIDECALCIUM HYDROXIDEPF5DZW74VNINJECTION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
16 equally ranked IID candidates
CALCIUM HYDROXIDECALCIUM HYDROXIDEPF5DZW74VNINJECTION / INTRAVENOUS3.7 mgExact identifier — unii candidate
16 equally ranked IID candidates
BENTONITEBENTONITEA3N5ZCN45CLOTION / TOPICAL5 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
BENTONITEBENTONITEA3N5ZCN45CLOTION / TOPICAL5 %w/wExact identifier — unii+route+dosage form
4 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
CalamineFERRIC OXIDE REDTopco Associates LLC2b32e720-ac71-4d60-bc06-e28a00f8a4502026-02-13Warnings, Adverse reactionsExact identifier
ndc (package): 36800-063-34
ndc (package): 36800-063-30
ndc (package): 36800-063-26
ndc (product): 36800-063
ndc11 (package): 36800006334
ndc11 (package): 36800006330
ndc11 (package): 36800006326
spl id: 4ab7ad96-87b5-6284-e063-6294a90ae847
spl set id: 2b32e720-ac71-4d60-bc06-e28a00f8a450

Reported adverse events (FAERS/openFDA)#

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