Calaclear

Manufacturer
Humco Holding Group, Inc.
Effective date
2021-12-23
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:45:53

Label at a glance#

ProductCalaclear
Active ingredientPRAMOXINE HYDROCHLORIDE, ZINC ACETATE
Label structure25 sections

Dosage and administration

Adults and children 2 yrs. 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: Consult a doctor before use.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Humco Calamine Lotion

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Pramoxine HCl 1%

Purpose

OTC - PURPOSE SECTION

External Analgesic

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Acetate 0.1%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Use

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

WARNINGS SECTION

For external use only. Use only as directed.

Avoid contact with eyes and mucous membranes.

Ask a doctor before using

OTC - ASK DOCTOR SECTION

on children under 2 years of age.

When using this product. Discontinue use if 

OTC - WHEN USING SECTION

condition worsens, does not improve or if symptoms persist for more than 7 days, or clear up and occur again within a few days. and consult a doctor.

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 immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 2 yrs. 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: Consult a doctor before use.

Other Information

OTHER SAFETY INFORMATION

  • store at room temperature 15 o – 30 oC (50 o – 85 oF)

Inactive Ingredient

INACTIVE INGREDIENT SECTION

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

GNP Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GNPClear.jpgGNPClear.jpg

Leader Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LDRClear.jpgLDRClear.jpg

Quality Choice Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

QCClear.jpgQCClear.jpg

Sunmark Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SMClear.jpgSMClear.jpg

Publix Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PublixClear.jpgPublixClear.jpg

Premiere Value Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PVPV

DDM Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DDMClear.jpgDDMClear.jpg

CVS Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS CalaclearCVS CalaclearCVSCVS

Harris Teeter Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HTHT

Best Choice Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Best ChoiceBest Choice

HEB Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HEBHEB

Equate Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Equate CalaclearEquate CalaclearEquateEquate

WM Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

WMClear.jpgWMClear.jpg

RA Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RAClear.jpgRAClear.jpg

Top Care Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TCClear.jpgTCClear.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1248193CALACLEAR 1 % / 0.1 % Topical LotionPSN5
1234546pramoxine HCl 1 % / zinc acetate 0.1 % Topical LotionPSN5
1248193pramoxine hydrochloride 10 MG/ML / zinc acetate 1 MG/ML Topical Lotion [Calaclear]SBD5
1234546pramoxine hydrochloride 10 MG/ML / zinc acetate 1 MG/ML Topical LotionSCD5
1248193Calaclear (pramoxine hydrochloride 1 % / zinc acetate 0.1 % ) Topical LotionSY5
1234546pramoxine HCl 1 % / zinc acetate 0.1 % 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0395-9108-962022-07-29C16284748780-1e4f33bdf-aea2-d8a0-e053-dadaa90a6e4ePrivate Label Calaclear

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0395-9108-96Calaclear177 mL in 1 BOTTLE, PLASTICLOTION1775

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0395-9108CALACLEAR (PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE) LOTION [HUMCO HOLDING GROUP, INC.]5Legacy NDC, 1 package rows20211224_6051d390-ece7-1d00-e053-2a91aa0addf6.zip

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
0395-91080395-9108-96

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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
d3d10ec1-fa51-c138-e053-2a95a90a1f6e6051d390-ece7-1d00-e053-2a91aa0addf62021-12-23WarningsExact identifier
spl id: d3d10ec1-fa51-c138-e053-2a95a90a1f6e
spl set id: 6051d390-ece7-1d00-e053-2a91aa0addf6

Reported adverse events (FAERS/openFDA)#

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