FDA.reportPublic FDA data

Freskaro Calamine Lotion

Manufacturer
Pharma Nobis, LLC
Effective date
2026-05-26
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:59:04

Label at a glance#

ProductCalamine
Active ingredientFERRIC OXIDE RED, ZINC OXIDE
Label structure13 sections

Indications and uses

Dries the oozing and weeping of 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, not more than 3 to 4 times daily as needed for comfort. Children under 2 years 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%

Uses

INDICATIONS & USAGE SECTION

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

Purpose

OTC - PURPOSE SECTION

Skin protectant

Warnings

WARNINGS SECTION

For external use only. Use only as directed.

Avoid contact with eyes and mucous membranes.

Ask a doctor before using on children under 2 years of age.

Stop use and ask a doctor if

OTC - WHEN USING SECTION

condition worsens, does not improve or if 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

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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, not more than 3 to 4 times daily as needed for comfort.

Children under 2 years 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

Avicel, Bentonite Magma, Calcium Hydroxide, Carrageenan, Glycerin, Purified Water, and Xanthan Gum

Questions

OTC - QUESTIONS SECTION

Questions or Comments? 1-833-551-0932

2026 Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Freskaro Calamine 2026Freskaro Calamine 2026

label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Freskaro Calamine 5-16-23Freskaro Calamine 5-16-23

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
617954calamine 8 % / zinc oxide 8 % Topical LotionPSN3
617954calamine 80 MG/ML / zinc oxide 80 MG/ML Topical LotionSCD3
617954calamine 8 % / zinc oxide 8 % Topical LotionSY3
617954Calamine 80 MG/ML / ZNO 80 MG/ML Topical LotionSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130382645418960GTIN-13: 0382645418960
EAN-13: 0382645418960
GTIN-12: 382645418960
UPC-A: 382645418960
GTIN storage (14 digits): 00382645418960		Freskaro Calamine 5 26 2026.jpg, Freskaro Calamine 5-16-23.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82645-418-96Calamine177 mL in 1 BOTTLE, PLASTICLOTION1773

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82645-41882645-418-96

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
FERRIC OXIDE RED1K09F3G675ACTIB
BENTONITEA3N5ZCN45CIACT
CARRAGEENAN5C69YCD2YJIACT
XANTHAN GUMTTV12P4NEEIACT
CALCIUM HYDROXIDEPF5DZW74VNIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
ZINC OXIDESOI2LOH54ZACTIM

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 OXIDEPharma Nobis, LLCfbcfa541-beda-06de-e053-6294a90a92982026-05-26WarningsExact identifier
ndc (package): 82645-418-96
ndc (product): 82645-418
ndc11 (package): 82645041896
spl id: 52b97551-89e2-c3b8-e063-6394a90af476
spl set id: fbcfa541-beda-06de-e053-6294a90a9298

Reported adverse events (FAERS/openFDA)#

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