Health Care Calamine Lotion

Manufacturer: Great Lakes Wholesale, Marketing and Sales Inc | Pharma Nobis, LLC
Effective date: 2023-12-20
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-06-01 00:05:08

Label at a glance#

ProductHealth Care Calamine

Active ingredientZINC OXIDE

Label structure12 sections

Indications and uses

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

Dosage and administration

Adults and children 6 mo. of age and older: Shake well before using. Cleanse the skin with soap and water. Let dry before each use. Apply lotion to the affected area using cotton or soft cloth, as often as needed for comfort. Children under 6 mo. 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%

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 and other skin irritations.

Warnings

WARNINGS SECTION

For external use only. Use only as directed.

Avoid contat with eyes and moucous membranes.

Ask a doctor

OTC - ASK DOCTOR SECTION

before using on children under 6 years of age.

Stop use and ask a doctor if

Condition worsens
Symptoms last for 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

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

Directions

DOSAGE & ADMINISTRATION SECTION

Children under 6 mo. of age: Consult a doctor before use.

Other information

OTHER SAFETY INFORMATION

Store at room temperature 15-30C (59-86F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Bentonite Magma, Calcium Hydroxide, Glycerin, and Purified Water.

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label

New Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

capture

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
64092-413-96	Health Care Calamine	177 mL in 1 BOTTLE, PLASTIC	LOTION	177		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64092-413	HEALTH CARE CALAMINE (CALAMINE 8% AND ZINC OXIDE 8%) LOTION [GREAT LAKES WHOLESALE, MARKETING AND SALES INC]	5	Current NDC, Legacy NDC, 1 package rows	20231221_5d8f02fb-0794-8ec2-e053-2991aa0aac63.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

Health Care Calamine
Calamine 8% and Zinc Oxide 8%
BENTONITE
CALCIUM HYDRIDE
GLYCERIN
WATER
ZINC OXIDE
ZINC CATION

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
64092-413	64092-413-96

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
BENTONITE	A3N5ZCN45C	IACT
CALCIUM HYDRIDE	WY779SQ0XW	IACT
GLYCERIN	PDC6A3C0OX	IACT
WATER	059QF0KO0R	IACT
ZINC OXIDE	SOI2LOH54Z	ACTIM

Source Document#

Source XML · Source PDF

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
Health Care Calamine	CALAMINE 8% AND ZINC OXIDE 8%	Great Lakes Wholesale, Marketing and Sales Inc	5d8f02fb-0794-8ec2-e053-2991aa0aac63	2023-12-20	Warnings	Exact identifier ndc (package): 64092-413-96 ndc (product): 64092-413 ndc11 (package): 64092041396 spl id: 0cf4d771-f6b1-ec8c-e063-6394a90a3551 spl set id: 5d8f02fb-0794-8ec2-e053-2991aa0aac63

Reported adverse events (FAERS/openFDA)#

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