FDA.reportPublic FDA data

Calamine Phenolated Topical Suspension

Manufacturer
Amerisource Bergen | Pharma Nobis, LLC
Effective date
2023-12-14
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 21:18:24

Label at a glance#

ProductCalamine Phenolated Topical Suspension
Active ingredientZINC OXIDE, PHENOL
Label structure17 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 

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Good Neighbor Pharmacy    NDC 24385-407-96

Calamine Topical Suspension USP

External Analgesic/Skin Prtectant

Phenolated

6FL OZS (177 mL)

image descriptionimage description

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24385-407CALAMINE PHENOLATED TOPICAL SUSPENSION (CALAMINE AND ZINC OXIDE AND PHENOL) LOTION [AMERISOURCE BERGEN]6Legacy NDC20231215_f20f6e01-aad3-45ff-99de-2788de86d4cb.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24385-407-96ML - Milliliter24385-40781e8785e-bf47-4305-ad5a-b5393e50848412013-07-02

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
24385-40724385-407-96

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
WATER059QF0KO0RIACT
BENTONITEA3N5ZCN45CIACT
CALCIUM HYDROXIDEPF5DZW74VNIACT
GLYCERINPDC6A3C0OXIACT
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 2 · 90 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, EXTENDED RELEASE / ORAL265 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / DENTAL15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, EMULSION / INTRAVENOUS24100 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
BENTONITEBENTONITEA3N5ZCN45CSHAMPOO, SUSPENSION / TOPICAL3.25 %w/vExact identifier — unii candidate
11 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / ORAL300 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, COATED / ORAL14.21 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / TRANSDERMAL306.2 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXEMULSION / INTRAVENOUS2.2 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXMOUTHWASH / BUCCAL100 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii candidate
75 equally ranked IID candidates
BENTONITEBENTONITEA3N5ZCN45CSUPPOSITORY / VAGINAL288.1 mgExact identifier — unii candidate
11 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / OPHTHALMIC0.88 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii candidate
75 equally ranked IID candidates
BENTONITEBENTONITEA3N5ZCN45CCREAM / TOPICAL4.1 %w/wExact identifier — unii candidate
11 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / VAGINAL60 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / ORAL42 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii candidate
75 equally ranked IID candidates
CALCIUM HYDROXIDECALCIUM HYDROXIDEPF5DZW74VNSUSPENSION / ORALADJ PHExact identifier — unii candidate
4 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / AURICULAR (OTIC)25 mgExact identifier — unii candidate
75 equally ranked IID candidates
BENTONITEBENTONITEA3N5ZCN45CTABLET, COATED / ORAL1.8 mgExact identifier — unii candidate
11 equally ranked IID candidates
BENTONITEBENTONITEA3N5ZCN45CCAPSULE / ORALADJ PHExact identifier — unii candidate
11 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAMUSCULAR450 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUPPOSITORY / VAGINAL227.9 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TRANSDERMAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPONGE / TOPICAL2 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAVENOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / TOPICAL18144 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / SUBCUTANEOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / OPHTHALMIC6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / ORAL750 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / VAGINALNAExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, CHEWABLE / ORAL12 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii candidate
75 equally ranked IID candidates
BENTONITEBENTONITEA3N5ZCN45CSUSPENSION / ORAL65 mg/5mlExact identifier — unii candidate
11 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, LIQUID FILLED / ORAL185 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUPPOSITORY / RECTAL440 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCONCENTRATE / ORAL1800 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS225 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM, AUGMENTED / TOPICAL55 mgExact identifier — unii candidate
75 equally ranked IID candidates
BENTONITEBENTONITEA3N5ZCN45CPOWDER, DENTIFRICE / DENTAL0.05 mg/mgExact identifier — unii candidate
11 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / PERIODONTAL0.53 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / SUBCUTANEOUS450 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSHAMPOO / TOPICAL5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
BENTONITEBENTONITEA3N5ZCN45CLOTION / TOPICAL5 %w/wExact identifier — unii candidate
11 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / AURICULAR (OTIC)63.64 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGUM, CHEWING / BUCCAL230 mgExact identifier — unii candidate
75 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
5370b841-ab6a-4665-e063-6294a90a2580f20f6e01-aad3-45ff-99de-2788de86d4cb2026-06-04WarningsExact identifier
spl set id: f20f6e01-aad3-45ff-99de-2788de86d4cb

Reported adverse events (FAERS/openFDA)#

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