Calamine

Manufacturer: Preferred Pharmaceuticals Inc.
Effective date: 2025-02-12
Label type: HUMAN OTC DRUG LABEL
Version: 6
Source: full-release
Hydrated at: 2026-06-01 00:55:12

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

Contacts and useful links#

PhoneLabel contact(800) 616-2471

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

(800) 616-2471

Adverse reactions

ADVERSE REACTIONS SECTION

Distributed By:

MAJOR PHARMACEUTICALS

17177 N LAUREL PARK DRIVE, SUITE 233

Livonia, MI 48152

Re-Order No 014282 M-97

Rev. 10/16

Relabeled By: Preferred Pharmaceuticals Inc.

principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68788-0292-1

MAJOR

Calamine

Lotion

Calamine Topical Suspension USP

Skin Protectant

Poison Ivy, Oak, Sumac

Drying Lotion

Shake well before using

6 FL OZ (177 mL)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
617954	calamine 8 % / zinc oxide 8 % Topical Lotion	PSN	6
617954	calamine 80 MG/ML / zinc oxide 80 MG/ML Topical Lotion	SCD	6
617954	calamine 8 % / zinc oxide 8 % Topical Lotion	SY	6
617954	Calamine 80 MG/ML / ZNO 80 MG/ML Topical Lotion	SY	6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68788-0292-1	Calamine	177 mL in 1 BOTTLE, PLASTIC	LOTION	177		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-0292	CALAMINE (FERRIC OXIDE RED) LOTION [PREFERRED PHARMACEUTICALS INC.]	6	Current NDC, Legacy NDC, 1 package rows	20250215_326f3d80-c1bf-4cf0-a662-58e02ed7ee67.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-0292-1	ML - Milliliter	68788-0292	f4aef026-c890-422d-90f1-6ad4552ab24a	1	2018-06-11
0904-2533-21	ML - Milliliter	0904-2533	918d193f-eb73-474a-b375-ecfe47fd756e	1	2014-10-03

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

Calamine
FERRIC OXIDE RED
ZINC OXIDE
BENTONITE
CALCIUM HYDROXIDE
GLYCERIN
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
68788-0292	68788-0292-1
0904-2533

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
Name	UNII	Kind
FERRIC OXIDE RED	1K09F3G675	ACTIB
ZINC OXIDE	SOI2LOH54Z	ACTIB
BENTONITE	A3N5ZCN45C	IACT
CALCIUM HYDROXIDE	PF5DZW74VN	IACT
GLYCERIN	PDC6A3C0OX	IACT
WATER	059QF0KO0R	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Calamine	FERRIC OXIDE RED	Major Pharmaceuticals	c25be68d-834a-4959-8d47-01ec789406ba	2026-02-04	Warnings, Adverse reactions	Exact identifier ndc (product): 0904-2533
Calamine	FERRIC OXIDE RED	Preferred Pharmaceuticals Inc.	326f3d80-c1bf-4cf0-a662-58e02ed7ee67	2025-02-12	Warnings, Adverse reactions	Exact identifier ndc (package): 68788-0292-1 ndc (product): 68788-0292 ndc11 (package): 68788029201 spl id: 671e5bc7-7fa2-48d7-b251-9b1249d2dfa6 spl set id: 326f3d80-c1bf-4cf0-a662-58e02ed7ee67

Reported adverse events (FAERS/openFDA)#

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