Top Care Calamine Lotion

Manufacturer: TOPCO ASSOCIATES LLC | Pharma Nobis, LLC
Effective date: 2023-12-18
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-06-01 00:04:50

Label at a glance#

ProductTopCare Calamine

Active ingredientZINC OXIDE

Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Calamine 8% and Zinc Oxide 8%

OTC - PURPOSE SECTION

Skin protectant

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

For external use only. Use only as directed.

Avoid contact with eyes and mucous membranes.

Ask a doctor before using on chilren 2 years of age.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

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 (8/2021)

INACTIVE INGREDIENT SECTION

Bentonite magma, calcium hydroxide, glycerin, purified water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Top Care CalamineTCCal.jpgcl

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
617954	calamine 8 % / zinc oxide 8 % Topical Lotion	PSN	5
617954	calamine 80 MG/ML / zinc oxide 80 MG/ML Topical Lotion	SCD	5
617954	calamine 8 % / zinc oxide 8 % Topical Lotion	SY	5
617954	Calamine 80 MG/ML / ZNO 80 MG/ML Topical Lotion	SY	5

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
ZINC CATION Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f47a510b-6679-4664-b2d6-47b5c4afe7cc	Product name	4	20260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
190f2a5b-bbc8-65c7-fcb0-97891307b917	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
36800-702-96	TopCare Calamine	177 mL in 1 CONTAINER	LOTION	177		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-702	TOPCARE CALAMINE (CALAMINE 8% AND ZINC OXIDE 8% LOTION) LOTION [TOPCO ASSOCIATES LLC]	5	Current NDC, Legacy NDC, 1 package rows	20231219_8dcf134e-0427-0c43-e053-2995a90a7c26.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

TopCare Calamine
calamine 8% and zinc oxide 8% lotion
BENTONITE
CARRAGEENAN
XANTHAN GUM
WATER
CALCIUM HYDROXIDE
MICROCRYSTALLINE CELLULOSE
GLYCERIN
ZINC OXIDE
ZINC CATION

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
36800-702	36800-702-96

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
Name	UNII	Kind
BENTONITE	A3N5ZCN45C	IACT
CARRAGEENAN	5C69YCD2YJ	IACT
XANTHAN GUM	TTV12P4NEE	IACT
WATER	059QF0KO0R	IACT
CALCIUM HYDROXIDE	PF5DZW74VN	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
GLYCERIN	PDC6A3C0OX	IACT
ZINC OXIDE	SOI2LOH54Z	ACTIM

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TopCare Calamine	CALAMINE 8% AND ZINC OXIDE 8% LOTION	TOPCO ASSOCIATES LLC	8dcf134e-0427-0c43-e053-2995a90a7c26	2023-12-18	Warnings	Exact identifier ndc (package): 36800-702-96 ndc (product): 36800-702 ndc11 (package): 36800070296 spl id: 0ccb3ccc-3531-2d08-e063-6394a90ac91a spl set id: 8dcf134e-0427-0c43-e053-2995a90a7c26

Reported adverse events (FAERS/openFDA)#

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