FDA.reportPublic FDA data

Freskaro Calamine Plus

Manufacturer
Pharma Nobis, LLC
Effective date
2026-04-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:53:56

Label at a glance#

ProductFreskaro Calamine Plus
Active ingredientZINC OXIDE, PRAMOXINE HYDROCHLORIDE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Calamine 8%

Pramoxine HCl 1%

OTC - PURPOSE SECTION

  • Skin Protectant
  • External Analgesic

INDICATIONS & USAGE SECTION

Dries the oozing and weeping, and temporarily relieves pain and itching of poison ivy, poison oak, and poison sumac or other minor skin irritations.

WARNINGS SECTION

For external use only. Use only as directed.

  • Avoid contact with eyes and mucous membranes,

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age and older: Shake well before using. Cleanse the skin with soap and water and let dry before each use. Apply lotion to the affected area using cotton or soft cloth, not more than 3 to 4 times daily as needed for comfort.

Children under 2 years of age: do not use, consult a doctor.

Other information

OTHER SAFETY INFORMATION

Store at room temperature 15 - 30C (59 - 86F)

INACTIVE INGREDIENT SECTION

SH Alcohol 38B 2.5%, Camphor, Diazolidinyl Urea, Fragrances, Glycerin, Hypromellose, Methylparaben, Polysorbate 80, Propylene Glycol, Propylparabaren and Purified water

Questions or Comments?

OTC - QUESTIONS SECTION

1-833-551-0932

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Freskaro Calamine Plus 2026Freskaro Calamine Plus 2026

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1234532calamine 8 % / pramoxine HCl 1 % Topical LotionPSN1
1234532calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical LotionSCD1
1234532calamine 8 % / pramoxine hydrochloride 1 % Topical LotionSY1

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-130382645420963GTIN-13: 0382645420963
EAN-13: 0382645420963
GTIN-12: 382645420963
UPC-A: 382645420963
GTIN storage (14 digits): 00382645420963		Freskaro Calamine Plus 4 15 2026.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82645-420-96Freskaro Calamine Plus177 mL in 1 BOTTLE, PLASTICLOTION1771

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82645-42082645-420-96

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
HYPROMELLOSES3NXW29V3WOIACT
GLYCERINPDC6A3C0OXIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
POLYSORBATE 806OZP39ZG8HIACT
WATER059QF0KO0RIACT
ZINC OXIDESOI2LOH54ZACTIM
PRAMOXINE HYDROCHLORIDE88AYB867L5ACTIB

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
Freskaro Calamine PlusZINC OXIDE LOTIONPharma Nobis, LLC4f85bdc7-8fed-f1f5-e063-6394a90a63582026-04-15WarningsExact identifier
ndc (package): 82645-420-96
ndc (product): 82645-420
ndc11 (package): 82645042096
spl id: 4f85c89b-114c-d84d-e063-6294a90aa32a
spl set id: 4f85bdc7-8fed-f1f5-e063-6394a90a6358

Reported adverse events (FAERS/openFDA)#

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