Calamine Lotion

Manufacturer
Marie's Original Formulas LLC
Effective date
2026-07-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-07-23 05:10:07

Label at a glance#

ProductCalamine
Active ingredientFERRIC OXIDE RED, ZINC OXIDE
Label structure12 sections

Indications and uses

Temporarily relieves itching associated with: • poison ivy • poison oak • poison sumac • insect bites • minor skin irritations Helps dry the oozing and weeping caused by poison ivy, poison oak, and poison sumac. Temporarily protects irritated skin.

Dosage and administration

Shake well before use. Adults and children 2 years of age and older: Apply to the affected area not more than 3 to 4 times daily. Children under 2 years of age: Ask a doctor.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ferric Oxide Red 80 mg in 1 mL
Zinc Oxide 80 mg in 1 mL

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves itching associated with:

• poison ivy

• poison oak

• poison sumac

• insect bites

• minor skin irritations

Helps dry the oozing and weeping caused by poison ivy, poison oak, and poison sumac.

Temporarily protects irritated skin.

When using this product

OTC - WHEN USING SECTION

Avoid contact with eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

Condition worsens.

Symptoms last more than 7 days.

Symptoms 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 use.

Adults and children 2 years of age and older:
Apply to the affected area not more than 3 to 4 times daily.

Children under 2 years of age:
Ask a doctor.

Other information

OTHER SAFETY INFORMATION

Store at 20°–25°C (68°–77°F).

Protect from freezing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water

Bentonite Magma

Calcium Hydroxide Solution

Glycerin

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-888-48-MARIE

Warnings

WARNINGS SECTION

For external use only.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Calamine Lotion

Calamine Topical Suspension USP

Skin Protectant

Poison Ivy, Oak and Sumac Drying Lotion

Relieves Itching

Helps Dry Oozing and Weeping

Protects and Soothes Irritated Skin

Shake Well

For External Use Only

Net Contents 6 fl oz (177 mL)

FrontFront

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87541-63287541-632-72

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC571083ce-cd35-a638-e063-6394a90ae4c72026-07-20WarningsExact identifier
ndc (package): 87541-632-72
ndc (product): 87541-632
ndc11 (package): 87541063272
spl id: 571083ce-cd36-a638-e063-6394a90ae4c7
spl set id: 571083ce-cd35-a638-e063-6394a90ae4c7

Reported adverse events (FAERS/openFDA)#

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