FDA.reportPublic FDA data

Calamine Phenolated Topical Suspension

Manufacturer
Pharma Nobis, LLC
Effective date
2023-12-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:05:44

Label at a glance#

ProductCalamine Phenolated Topical Suspension
Active ingredientZINC OXIDE, PHENOL
Label structure18 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

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.

SPL UNCLASSIFIED SECTION

Distribted by AmerisourceBergen
1300 Morris Drive, chesterbrook, PA 19087 

Good Neighbor Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

Sunmark Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SMPhen.jpgSMPhen.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
991369calamine 8 % / phenol 1 % / zinc oxide 8 % Topical LotionPSN2
991369calamine 80 MG/ML / phenol 10 MG/ML / zinc oxide 80 MG/ML Topical LotionSCD2
991369calamine 8 % / phenol 1 % / zinc oxide 8 % Topical LotionSY2
991369calamine 8 % / phenol 1 % / zinc oxide 8 % Topical SuspensionSY2
991369Calamine 80 MG/ML / phenol 10 MG/ML / ZNO 80 MG/ML Topical LotionSY2

DailyMed Pharmacologic Classes#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82645-921-96Calamine Phenolated Topical Suspension177 mL in 1 BOTTLE, PLASTICLOTION1772

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82645-921CALAMINE PHENOLATED TOPICAL SUSPENSION (CALAMINE AND ZINC OXIDE AND PHENOL) LOTION [PHARMA NOBIS, LLC]2Current NDC, Legacy NDC, 1 package rows20231227_e42fbdcc-3291-7761-e053-2995a90a7172.zip

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
82645-92182645-921-96

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

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 PHENOLPharma Nobis, LLCe42fbdcc-3291-7761-e053-2995a90a71722023-12-26WarningsExact identifier
ndc (package): 82645-921-96
ndc (product): 82645-921
ndc11 (package): 82645092196
spl id: 0d6ccb8f-d9bf-28e6-e063-6294a90a8a87
spl set id: e42fbdcc-3291-7761-e053-2995a90a7172

Reported adverse events (FAERS/openFDA)#

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