Caldyphen Clear

Manufacturer
Amerisource Bergen
Effective date
2026-05-27
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:59:12

Label at a glance#

ProductCaldyphen Clear
Active ingredientPRAMOXINE HYDROCHLORIDE, ZINC ACETATE
Label structure15 sections

Indications and uses

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

Dosage and administration

Adults and children 2 yrs. of age and older. Shake well before using. cleanse the skin with soap and water. 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 unedr 2 yrs. of age. Consult a doctor before use.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

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

Uses

INDICATIONS & USAGE SECTION

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

Warnings 

WARNINGS SECTION

For External Use Only. Use only as directed. Avoid contact with eye and mucous membranes. ask a doctor before using on children under 2 years of age.

Stop use and as a doctor if

OTC - ASK DOCTOR SECTION

condition worsens. Symptoms last for more than 7 days or celar 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 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. 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 unedr 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 Methylcellulose, Methylparaben, Polysorbate 80, Propylene Glycol, Propylparaben, and Purified Water.

Other information

OTHER SAFETY INFORMATION

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

SPL UNCLASSIFIED SECTION

Distributed by: AmerisourceBergen

1300 Morris Drive, Chesterbrook, PA 19087

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GNPCaldy.jpgGNPCaldy.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1234546pramoxine HCl 1 % / zinc acetate 0.1 % Topical LotionPSN4
1234546pramoxine hydrochloride 10 MG/ML / zinc acetate 1 MG/ML Topical LotionSCD4
1234546pramoxine HCl 1 % / zinc acetate 0.1 % Topical LotionSY4

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130087701400452GTIN-13: 0087701400452
EAN-13: 0087701400452
GTIN-12: 087701400452
UPC-A: 087701400452
GTIN storage (14 digits): 00087701400452
GNPCaldy.jpg

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
24385-439-302022-07-29C16284748780-19d75b9d0-c229-f424-e053-dadaa90a57ceCaldyphen Clear
24385-439-302020-03-18C16284748780-19d75b9d0-c229-f424-e053-dadaa90a57ceCaldyphen Clear
24385-439-302020-01-31C16284748780-19d75b9d0-c229-f424-e053-dadaa90a57ceCaldyphen Clear

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24385-439-30Caldyphen Clear177 mL in 1 BOTTLE, PLASTICLOTION1774

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24385-439-30ML - Milliliter24385-43991af2a34-0e06-412d-945e-e515b9815f8a12013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PRAMOXINE HYDROCHLORIDEACTIVE INGREDIENT88AYB867L51
ZINC ACETATEACTIVE INGREDIENTFM5526K07A1
PRAMOXINEACTIVE MOIETY068X84E0561
ZINC CATIONACTIVE MOIETY13S1S8SF371
CAMPHOR (NATURAL)INACTIVE INGREDIENTN20HL7Q9411
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW41
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
HYDROXYPROPYL METHYLCELLULOSE E5 [II]INACTIVE INGREDIENTR75537T0T41
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8H1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
24385-43924385-439-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

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 · 58 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
HYDROXYPROPYL METHYLCELLULOSE E5 [II]HYPROMELLOSE 2910 (5 MPA.S)R75537T0T4TABLET, DELAYED RELEASE / ORAL103 mgExact identifier — unii candidate
46 equally ranked IID candidates
HYDROXYPROPYL METHYLCELLULOSE E5 [II]HYPROMELLOSE 2910 (5 MPA.S)R75537T0T4TABLET, FILM COATED / ORAL264 mgExact identifier — unii candidate
46 equally ranked IID candidates
HYDROXYPROPYL METHYLCELLULOSE E5 [II]HYPROMELLOSE 2910 (5 MPA.S)R75537T0T4GUM, CHEWING / BUCCAL336 mgExact identifier — unii candidate
46 equally ranked IID candidates
HYDROXYPROPYL METHYLCELLULOSE E5 [II]HYPROMELLOSE 2910 (5 MPA.S)R75537T0T4CAPSULE / ORAL930 mgExact identifier — unii candidate
46 equally ranked IID candidates
HYDROXYPROPYL METHYLCELLULOSE E5 [II]HYPROMELLOSE 2910 (5 MPA.S)R75537T0T4SYRUP / ORAL200 mgExact identifier — unii candidate
46 equally ranked IID candidates
HYDROXYPROPYL METHYLCELLULOSE E5 [II]HYPROMELLOSE 2910 (5 MPA.S)R75537T0T4FILM, SOLUBLE / ORAL201 mgExact identifier — unii candidate
46 equally ranked IID candidates
HYDROXYPROPYL METHYLCELLULOSE E5 [II]HYPROMELLOSE 2910 (5 MPA.S)R75537T0T4TABLET, EXTENDED RELEASE / ORAL670 mgExact identifier — unii candidate
46 equally ranked IID candidates
HYDROXYPROPYL METHYLCELLULOSE E5 [II]HYPROMELLOSE 2910 (5 MPA.S)R75537T0T4CAPSULE, EXTENDED RELEASE / ORAL1508 mgExact identifier — unii candidate
46 equally ranked IID candidates
HYDROXYPROPYL METHYLCELLULOSE E5 [II]HYPROMELLOSE 2910 (5 MPA.S)R75537T0T4SPRAY, METERED / NASAL1 mg/1mlExact identifier — unii candidate
46 equally ranked IID candidates
HYDROXYPROPYL METHYLCELLULOSE E5 [II]HYPROMELLOSE 2910 (5 MPA.S)R75537T0T4POWDER, FOR SUSPENSION / ORAL2940 mgExact identifier — unii candidate
46 equally ranked IID candidates
HYDROXYPROPYL METHYLCELLULOSE E5 [II]HYPROMELLOSE 2910 (5 MPA.S)R75537T0T4TABLET / ORAL1200 mgExact identifier — unii candidate
46 equally ranked IID candidates
HYDROXYPROPYL METHYLCELLULOSE E5 [II]HYPROMELLOSE 2910 (5 MPA.S)R75537T0T4SYRUP / ORAL200 mgExact identifier — unii candidate
46 equally ranked IID candidates
HYDROXYPROPYL METHYLCELLULOSE E5 [II]HYPROMELLOSE 2910 (5 MPA.S)R75537T0T4FILM / SUBLINGUAL4.68 mgExact identifier — unii candidate
46 equally ranked IID candidates
HYDROXYPROPYL METHYLCELLULOSE E5 [II]HYPROMELLOSE 2910 (5 MPA.S)R75537T0T4CAPSULE, DELAYED RELEASE / ORAL563 mgExact identifier — unii candidate
46 equally ranked IID candidates
HYDROXYPROPYL METHYLCELLULOSE E5 [II]HYPROMELLOSE 2910 (5 MPA.S)R75537T0T4SUSPENSION, EXTENDED RELEASE / ORAL727 mgExact identifier — unii candidate
46 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
HYDROXYPROPYL METHYLCELLULOSE E5 [II]HYPROMELLOSE 2910 (5 MPA.S)R75537T0T4TABLET, FILM COATED / ORAL264 mgExact identifier — unii candidate
46 equally ranked IID candidates
HYDROXYPROPYL METHYLCELLULOSE E5 [II]HYPROMELLOSE 2910 (5 MPA.S)R75537T0T4TABLET / ORAL1200 mgExact identifier — unii candidate
46 equally ranked IID candidates
HYDROXYPROPYL METHYLCELLULOSE E5 [II]HYPROMELLOSE 2910 (5 MPA.S)R75537T0T4CAPSULE, DELAYED RELEASE / ORAL563 mgExact identifier — unii candidate
46 equally ranked IID candidates
HYDROXYPROPYL METHYLCELLULOSE E5 [II]HYPROMELLOSE 2910 (5 MPA.S)R75537T0T4CAPSULE, EXTENDED RELEASE / ORAL1508 mgExact identifier — unii candidate
46 equally ranked IID candidates
HYDROXYPROPYL METHYLCELLULOSE E5 [II]HYPROMELLOSE 2910 (5 MPA.S)R75537T0T4FILM / SUBLINGUAL4.68 mgExact identifier — unii candidate
46 equally ranked IID candidates
HYDROXYPROPYL METHYLCELLULOSE E5 [II]HYPROMELLOSE 2910 (5 MPA.S)R75537T0T4TABLET, ORALLY DISINTEGRATING / ORAL25 mgExact identifier — unii candidate
46 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHLOTION / TOPICAL140 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
HYDROXYPROPYL METHYLCELLULOSE E5 [II]HYPROMELLOSE 2910 (5 MPA.S)R75537T0T4TABLET / BUCCAL5 mgExact identifier — unii candidate
46 equally ranked IID candidates
HYDROXYPROPYL METHYLCELLULOSE E5 [II]HYPROMELLOSE 2910 (5 MPA.S)R75537T0T4SUSPENSION, EXTENDED RELEASE / ORAL727 mgExact identifier — unii candidate
46 equally ranked IID candidates
HYDROXYPROPYL METHYLCELLULOSE E5 [II]HYPROMELLOSE 2910 (5 MPA.S)R75537T0T4TABLET, FILM COATED, EXTENDED RELEASE / ORAL107 mgExact identifier — unii candidate
46 equally ranked IID candidates
HYDROXYPROPYL METHYLCELLULOSE E5 [II]HYPROMELLOSE 2910 (5 MPA.S)R75537T0T4SPRAY / NASAL1 mg/1mlExact identifier — unii candidate
46 equally ranked IID candidates
HYDROXYPROPYL METHYLCELLULOSE E5 [II]HYPROMELLOSE 2910 (5 MPA.S)R75537T0T4SUSPENSION / ORAL975 mgExact identifier — unii candidate
46 equally ranked IID candidates
HYDROXYPROPYL METHYLCELLULOSE E5 [II]HYPROMELLOSE 2910 (5 MPA.S)R75537T0T4TABLET, ORALLY DISINTEGRATING / ORAL25 mgExact identifier — unii candidate
46 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LOTION / TOPICAL3392 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
HYDROXYPROPYL METHYLCELLULOSE E5 [II]HYPROMELLOSE 2910 (5 MPA.S)R75537T0T4TABLET, FOR SUSPENSION / ORAL76 mgExact identifier — unii candidate
46 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
DIAZOLIDINYL UREADIAZOLIDINYL UREAH5RIZ3MPW4LOTION / TOPICAL3 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
HYDROXYPROPYL METHYLCELLULOSE E5 [II]HYPROMELLOSE 2910 (5 MPA.S)R75537T0T4FILM, SOLUBLE / ORAL201 mgExact identifier — unii candidate
46 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHLOTION / TOPICAL140 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
HYDROXYPROPYL METHYLCELLULOSE E5 [II]HYPROMELLOSE 2910 (5 MPA.S)R75537T0T4POWDER, FOR SUSPENSION / ORAL2940 mgExact identifier — unii candidate
46 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TLOTION / TOPICAL351 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
HYDROXYPROPYL METHYLCELLULOSE E5 [II]HYPROMELLOSE 2910 (5 MPA.S)R75537T0T4SPRAY / NASAL1 mg/1mlExact identifier — unii candidate
46 equally ranked IID candidates
HYDROXYPROPYL METHYLCELLULOSE E5 [II]HYPROMELLOSE 2910 (5 MPA.S)R75537T0T4SPRAY, METERED / NASAL1 mg/1mlExact identifier — unii candidate
46 equally ranked IID candidates
HYDROXYPROPYL METHYLCELLULOSE E5 [II]HYPROMELLOSE 2910 (5 MPA.S)R75537T0T4TABLET, COATED / ORAL24 mgExact identifier — unii candidate
46 equally ranked IID candidates
HYDROXYPROPYL METHYLCELLULOSE E5 [II]HYPROMELLOSE 2910 (5 MPA.S)R75537T0T4POWDER / NASALNAExact identifier — unii candidate
46 equally ranked IID candidates
HYDROXYPROPYL METHYLCELLULOSE E5 [II]HYPROMELLOSE 2910 (5 MPA.S)R75537T0T4TABLET, CHEWABLE / ORAL120 mgExact identifier — unii candidate
46 equally ranked IID candidates
HYDROXYPROPYL METHYLCELLULOSE E5 [II]HYPROMELLOSE 2910 (5 MPA.S)R75537T0T4TABLET, COATED / ORAL24 mgExact identifier — unii candidate
46 equally ranked IID candidates
HYDROXYPROPYL METHYLCELLULOSE E5 [II]HYPROMELLOSE 2910 (5 MPA.S)R75537T0T4TABLET, FILM COATED, EXTENDED RELEASE / ORAL107 mgExact identifier — unii candidate
46 equally ranked IID candidates
HYDROXYPROPYL METHYLCELLULOSE E5 [II]HYPROMELLOSE 2910 (5 MPA.S)R75537T0T4TABLET / BUCCAL5 mgExact identifier — unii candidate
46 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LOTION / TOPICAL3392 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
HYDROXYPROPYL METHYLCELLULOSE E5 [II]HYPROMELLOSE 2910 (5 MPA.S)R75537T0T4CAPSULE / ORAL930 mgExact identifier — unii candidate
46 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TLOTION / TOPICAL351 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
HYDROXYPROPYL METHYLCELLULOSE E5 [II]HYPROMELLOSE 2910 (5 MPA.S)R75537T0T4SUSPENSION / ORAL975 mgExact identifier — unii candidate
46 equally ranked IID candidates
HYDROXYPROPYL METHYLCELLULOSE E5 [II]HYPROMELLOSE 2910 (5 MPA.S)R75537T0T4POWDER / NASALNAExact identifier — unii candidate
46 equally ranked IID candidates
DIAZOLIDINYL UREADIAZOLIDINYL UREAH5RIZ3MPW4LOTION / TOPICAL3 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
HYDROXYPROPYL METHYLCELLULOSE E5 [II]HYPROMELLOSE 2910 (5 MPA.S)R75537T0T4TABLET, FOR SUSPENSION / ORAL76 mgExact identifier — unii candidate
46 equally ranked IID candidates
HYDROXYPROPYL METHYLCELLULOSE E5 [II]HYPROMELLOSE 2910 (5 MPA.S)R75537T0T4TABLET, CHEWABLE / ORAL120 mgExact identifier — unii candidate
46 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HLOTION / TOPICAL15 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
HYDROXYPROPYL METHYLCELLULOSE E5 [II]HYPROMELLOSE 2910 (5 MPA.S)R75537T0T4TABLET, DELAYED RELEASE / ORAL103 mgExact identifier — unii candidate
46 equally ranked IID candidates
HYDROXYPROPYL METHYLCELLULOSE E5 [II]HYPROMELLOSE 2910 (5 MPA.S)R75537T0T4TABLET, EXTENDED RELEASE / ORAL670 mgExact identifier — unii candidate
46 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HLOTION / TOPICAL15 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
HYDROXYPROPYL METHYLCELLULOSE E5 [II]HYPROMELLOSE 2910 (5 MPA.S)R75537T0T4GUM, CHEWING / BUCCAL336 mgExact identifier — unii candidate
46 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
Caldyphen ClearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATEAmerisource Bergend8802e56-649e-4494-86ee-7ca8841cc28b2026-05-27WarningsExact identifier
ndc (package): 24385-439-30
ndc (product): 24385-439
ndc11 (package): 24385043930
spl id: 52d4acc7-7f67-f62a-e063-6394a90a245d
spl set id: d8802e56-649e-4494-86ee-7ca8841cc28b

Reported adverse events (FAERS/openFDA)#

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