Calamine

Manufacturer: FOODHOLD U.S.A. LLC | Vi Jon
Effective date: 2020-06-11
Label type: HUMAN OTC DRUG LABEL
Version: 7
Source: legacy-cache
Hydrated at: 2026-08-01 23:26:28

Label at a glance#

ProductCalamine

Active ingredientFERRIC OXIDE RED, ZINC OXIDE

Label structure12 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

Adverse Reaction Section

ADVERSE REACTIONS SECTION

DISTRIBUTED BY FOODHOLD U.S.A., LLC

LANDOVER, MD 20785

2016 S&S BRANDS LLC

QUALITY GUARANTEED OR YOUR MONEY BACK

063.000/063AA

principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CAREONE

Calamine

Lotion

CALAMINE TOPICAL

SUSPENSION USP

Skin Protectant

CALAMINE 8%

ZINC OXIDE 8%

POISON IVY, OAK, SUMACK

DRYING LOTION

OUR PHARMACISTS RECOMMEND

6 FL OZ (177 mL)

image description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
41520-063-30	2023-09-18	C162847	48780-1	d6a99b39-7523-a426-e053-dadaa90af4c2	Care One 063.001 063AA
41520-063-30	2022-01-28	C162847	48780-1	d6a99b39-7523-a426-e053-dadaa90af4c2	Care One 063.001 063AA

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
41520-063	41520-063-30

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
f3dc2e01-cc3f-4c66-86e2-ef43d60b6eea			261e4092-c986-488e-b8cf-e754a6403af7	2023-09-18	Warnings, Adverse reactions	Exact identifier spl set id: 261e4092-c986-488e-b8cf-e754a6403af7

Reported adverse events (FAERS/openFDA)#

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