Calamine Lotion

Manufacturer: Pierson Laboratories | Humco Holding Group, Inc.
Effective date: 2017-12-14
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:53:28

Label at a glance#

ProductCalamine

Active ingredientZINC OXIDE

Label structure11 sections

Indications and uses

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

Dosage and administration

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 6 months 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.

Ask a doctor before using on chilren 6 months of age.

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

Children under 6 months 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, glycerin, purified water.

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
617954	calamine 8 % / zinc oxide 8 % Topical Lotion	PSN	1
617954	calamine 80 MG/ML / zinc oxide 80 MG/ML Topical Lotion	SCD	1
617954	calamine 8 % / zinc oxide 8 % Topical Lotion	SY	1
617954	Calamine 80 MG/ML / ZNO 80 MG/ML Topical Lotion	SY	1

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0045591041964	GTIN-13: 0045591041964 EAN-13: 0045591041964 GTIN-12: 045591041964 UPC-A: 045591041964 GTIN storage (14 digits): 00045591041964	L041396370 Dollar Tree Calamine-OL-DL.jpg

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
45591-041-96	2022-07-29	C162847	48780-1	e4f33bdf-9e31-d8a0-e053-dadaa90a6e4e	Calamine Lotion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
45591-041-96	Calamine	177 mL in 1 BOTTLE, PLASTIC	LOTION	177		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45591-041	CALAMINE (CALAMINE 8% AND ZINC OXIDE 8%) LOTION [PIERSON LABORATORIES]	1	Legacy NDC, 1 package rows	20171214_6050b319-9902-333d-e053-2a91aa0ad1f3.zip

Products#

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

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

Calamine
Calamine 8% and Zinc Oxide 8%
BENTONITE
CARRAGEENAN
XANTHAN GUM
ZINC OXIDE
ZINC CATION
CALCIUM HYDROXIDE
GLYCERIN
WATER
MICROCRYSTALLINE CELLULOSE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
45591-041	45591-041-96

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
ZINC OXIDE	SOI2LOH54Z	ACTIM
CALCIUM HYDROXIDE	PF5DZW74VN	IACT
GLYCERIN	PDC6A3C0OX	IACT
WATER	059QF0KO0R	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT

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
6050b319-9903-333d-e053-2a91aa0ad1f3			6050b319-9902-333d-e053-2a91aa0ad1f3	2017-12-14	Warnings	Exact identifier spl id: 6050b319-9903-333d-e053-2a91aa0ad1f3 spl set id: 6050b319-9902-333d-e053-2a91aa0ad1f3

Reported adverse events (FAERS/openFDA)#

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