FDA.reportPublic FDA data

Calamine Phenolated Topical Suspension

Manufacturer
Humco Holding Group, Inc | Pharma Nobis, LLC
Effective date
2023-12-15
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:04:38

Label at a glance#

ProductCalamine Phenolated Topical Suspension
Active ingredientZINC OXIDE, PHENOL
Label structure15 sections

Indications and uses

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

Dosage and administration

Adult and children 2 years of age and older: Cleanse the skin with soap and water and let dry before each use. Apply product to the affected area using cotton or soft cloth, as often 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 Ingredient

OTC - ACTIVE INGREDIENT SECTION

Calamine 8%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 8%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Liquefied Phenol 1%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

Dries the oozing and weeping and temporarily 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.
  • Do not apply to large areas of the body or in large quantities, particularly over raw or blistered areas.
  • If applied to fingers or toes do not bandage.

Ask a doctor

OTC - ASK DOCTOR SECTION

before using on children under 2 years of age.

When using this product. Discontinue use if condition worsen or does not improve within 7 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 (Shake well before using)

DOSAGE & ADMINISTRATION SECTION

Adult and children 2 years of age and older: Cleanse the skin with soap and water and let dry before each use. Apply product to the affected area using cotton or soft cloth, as often 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

Bentonite Magma, Calcium Hydroxide, Glycerin, Purified Water.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Phenolated.jpgPhenolated.jpgcapturecapture

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
991369calamine 8 % / phenol 1 % / zinc oxide 8 % Topical LotionPSN6
991369calamine 80 MG/ML / phenol 10 MG/ML / zinc oxide 80 MG/ML Topical LotionSCD6
991369calamine 8 % / phenol 1 % / zinc oxide 8 % Topical LotionSY6
991369calamine 8 % / phenol 1 % / zinc oxide 8 % Topical SuspensionSY6
991369Calamine 80 MG/ML / phenol 10 MG/ML / ZNO 80 MG/ML Topical LotionSY6

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0395-0407-96Calamine Phenolated Topical Suspension177 mL in 1 BOTTLE, PLASTICLOTION1776

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0395-0407CALAMINE PHENOLATED TOPICAL SUSPENSION (CALAMINE AND ZINC OXIDE AND PHENOL) LOTION [HUMCO HOLDING GROUP, INC]6Current NDC, Legacy NDC, 1 package rows20231216_a3816729-be2b-4b4f-a609-953576cd2e3b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0395-0407-96ML - Milliliter0395-04076a929f43-d6bc-4088-b8db-caceb25c92a112014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PHENOLACTIVE INGREDIENT339NCG44TV1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z1
PHENOLACTIVE MOIETY339NCG44TV1
ZINC CATIONACTIVE MOIETY13S1S8SF371
BENTONITEINACTIVE INGREDIENTA3N5ZCN45C1
CALCIUM HYDROXIDEINACTIVE INGREDIENTPF5DZW74VN1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0395-04070395-0407-96

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENTONITEA3N5ZCN45CIACT
CALCIUM HYDROXIDEPF5DZW74VNIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ZINC OXIDESOI2LOH54ZACTIM
PHENOL339NCG44TVACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 12 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
BENTONITEBENTONITEA3N5ZCN45CLOTION / TOPICAL5 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CALCIUM HYDROXIDECALCIUM HYDROXIDEPF5DZW74VNCAPSULE, EXTENDED RELEASE / ORAL14 mgExact identifier — unii candidate
8 equally ranked IID candidates
CALCIUM HYDROXIDECALCIUM HYDROXIDEPF5DZW74VNSUSPENSION / ORALADJ PHExact identifier — unii candidate
8 equally ranked IID candidates
CALCIUM HYDROXIDECALCIUM HYDROXIDEPF5DZW74VNINJECTION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
8 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CALCIUM HYDROXIDECALCIUM HYDROXIDEPF5DZW74VNINJECTION / INTRAVENOUS3.7 mgExact identifier — unii candidate
8 equally ranked IID candidates
CALCIUM HYDROXIDECALCIUM HYDROXIDEPF5DZW74VNINJECTION / INTRAVENOUS3.7 mgExact identifier — unii candidate
8 equally ranked IID candidates
BENTONITEBENTONITEA3N5ZCN45CLOTION / TOPICAL5 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CALCIUM HYDROXIDECALCIUM HYDROXIDEPF5DZW74VNINJECTION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
8 equally ranked IID candidates
CALCIUM HYDROXIDECALCIUM HYDROXIDEPF5DZW74VNSUSPENSION / ORALADJ PHExact identifier — unii candidate
8 equally ranked IID candidates
CALCIUM HYDROXIDECALCIUM HYDROXIDEPF5DZW74VNCAPSULE, EXTENDED RELEASE / ORAL14 mgExact identifier — unii candidate
8 equally ranked IID candidates

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
Calamine Phenolated Topical SuspensionCALAMINE AND ZINC OXIDE AND PHENOLHumco Holding Group, Inca3816729-be2b-4b4f-a609-953576cd2e3b2023-12-15WarningsExact identifier
ndc (package): 0395-0407-96
ndc (product): 0395-0407
ndc11 (package): 00395040796
spl id: 0c92d58b-b1c7-dc2c-e063-6394a90a4d7a
spl set id: a3816729-be2b-4b4f-a609-953576cd2e3b

Reported adverse events (FAERS/openFDA)#

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