FDA.reportPublic FDA data

Private Label Calagesic Lotion

Manufacturer
Humco Holding Group, Inc.
Effective date
2020-06-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:18:27

Label at a glance#

ProductHumco Calagesic
Active ingredientZINC OXIDE, PRAMOXINE HYDROCHLORIDE
Label structure22 sections

Indications and uses

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

Dosage and administration

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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Calamine 8%

Pramoxine HCl 1%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

External analgesic

Uses

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

WARNINGS SECTION

For external use only. Use only as directed.

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

Stop ue and ask a doctor if

OTC - ASK DOCTOR SECTION

condition worsens. Symptoms last for more than 7days or clear up and occur again whitin a few days.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

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 Ingredients

INACTIVE INGREDIENT SECTION

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

Other information

OTHER SAFETY INFORMATION

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

Good Neighbor Pharmacy Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GNPCaldy.jpgGNPCaldy.jpg

Leader Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LDRCaldy.jpgLDRCaldy.jpg

Quality Choice Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

QCCaldy.jpgQCCaldy.jpg

Sunmark Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SMCaldy.jpgSMCaldy.jpg

Publix Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PublixPublix

Premier Value

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PVPV

CVS Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVSCVS

Vida Mia Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VMVM

Best Choice Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Best ChoiceBest Choice

HEB Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HEBHEB

DrugMart Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DMCaldy.jpgDMCaldy.jpg

Top care Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TCCaldy.jpgTCCaldy.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1234539CALAGESIC 8 % / 1 % Topical LotionPSN3
1234532calamine 8 % / pramoxine HCl 1 % Topical LotionPSN3
1234539calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Lotion [Calagesic]SBD3
1234532calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical LotionSCD3
1234539Calagesic (calamine 8 % / pramoxine hydrochloride 1 % ) Topical LotionSY3
1234532calamine 8 % / pramoxine hydrochloride 1 % Topical LotionSY3

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0395-9111-962022-07-29C16284748780-1e4f33bdf-b05e-d8a0-e053-dadaa90a6e4ePrivate Label Calagesic Lotion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0395-9111-96Humco Calagesic177 mL in 1 BOTTLE, PLASTICLOTION1773

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0395-9111HUMCO CALAGESIC (CALAMINE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.]3Legacy NDC, 1 package rows20200622_60530c40-c34d-5abf-e053-2991aa0a8eaf.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
0395-91110395-9111-96

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
CAMPHOR (NATURAL)N20HL7Q941IACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
GLYCERINPDC6A3C0OXIACT
METHYLPARABENA2I8C7HI9TIACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
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
a87aa488-3028-83c5-e053-2995a90adf5060530c40-c34d-5abf-e053-2991aa0a8eaf2020-06-19WarningsExact identifier
spl id: a87aa488-3028-83c5-e053-2995a90adf50
spl set id: 60530c40-c34d-5abf-e053-2991aa0a8eaf

Reported adverse events (FAERS/openFDA)#

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