FDA.reportPublic FDA data

Top Care Calagesic Lotion

Manufacturer
TOPCO ASSOCIATES LLC | Pharma Nobis, LLC
Effective date
2023-12-18
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:04:50

Label at a glance#

ProductTopCare Calagesic
Active ingredientZINC OXIDE, PRAMOXINE HYDROCHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Calamine 8%

Pramoxine Hydochloride 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, oak, and sumac or other skin irritations.

WARNINGS SECTION

For external use only. Use only as directed.

When using this product. Avoid contact with eyes and moucous membranes.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, seek profesional assistance or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION SECTION

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

Children under 2 yrs. of age. Consult a doctor before use.

INACTIVE INGREDIENT SECTION

SD Alcohol 38B 2.5%, Camphor, Diazolidinyl Urea, Fragrances, Glycerin, Hydroxypropyl Methycelulose, Methylparaben, Polysorbate 80, Propylene Glycol, Propylparaben and Purified Water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Top Care Calagesic 2022Top Care Calagesic 2022TCGesig.jpgTCGesig.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1234532calamine 8 % / pramoxine HCl 1 % Topical LotionPSN5
1234532calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical LotionSCD5
1234532calamine 8 % / pramoxine hydrochloride 1 % Topical LotionSY5

DailyMed Pharmacologic Classes#

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

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
36800-268-96TopCare Calagesic177 mL in 1 CONTAINERLOTION1775

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-268TOPCARE CALAGESIC (CALAMINE AND PRAMOXINE HYDROCHLORIDE LOTION) LOTION [TOPCO ASSOCIATES LLC]5Current NDC, Legacy NDC, 1 package rows20231219_8dced3ea-147b-3d46-e053-2a95a90aa1c0.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-26836800-268-96

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
CAMPHOR (NATURAL)N20HL7Q941IACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
WATER059QF0KO0RIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
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
TopCare CalagesicCALAMINE AND PRAMOXINE HYDROCHLORIDE LOTIONTOPCO ASSOCIATES LLC8dced3ea-147b-3d46-e053-2a95a90aa1c02023-12-18WarningsExact identifier
ndc (package): 36800-268-96
ndc (product): 36800-268
ndc11 (package): 36800026896
spl id: 0ccb3962-d499-0a6c-e063-6294a90a0d41
spl set id: 8dced3ea-147b-3d46-e053-2a95a90aa1c0

Reported adverse events (FAERS/openFDA)#

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