FDA.reportPublic FDA data

Caladryl

Manufacturer
Bausch Health US, LLC | Trillium Health Care Products Inc.
Effective date
2024-10-17
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:27:05

Label at a glance#

ProductCaladryl
Active ingredientFERRIC OXIDE RED, ZINC OXIDE, PRAMOXINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

temporarily relieves pain and itching associated with: rashes due to poison ivy, poison oak or poison sumac insect bites minor skin irritation minor cuts dries the oozing and weeping of poison ivy, poison oak and poison sumac

Dosage and administration

shake well before use adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily children under 2 years of age: ask a doctor

Storage and handling

store at 20° to 25°C (68° to 77°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose

Calamine 8%

Skin protectant

Pramoxine HCl 1%

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves pain and itching associated with:
    • rashes due to poison ivy, poison oak or poison sumac
    • insect bites
    • minor skin irritation
    • minor cuts
  • dries the oozing and weeping of poison ivy, poison oak and poison sumac

Warnings

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

When using this productdo not get into eyes

OTC - STOP USE SECTION

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if

  • condition worsens or does not improve within 7 days
  • symptoms persist for more than 7 days or clear up and occur again within a few days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well before use
  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at 20° to 25°C (68° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

SD alcohol 38-B, camphor, diazolidinyl urea, fragrance, hypromellose, methylparaben, polysorbate 80, propylene glycol, propylparaben, purified water, xanthan gum

Questions/Comments

OTC - QUESTIONS SECTION

call 1-800-321-4576

SPL UNCLASSIFIED SECTION

Distributed by:Bausch Health US, LLC, Bridgewater, NJ 08807 USA

©2020 Bausch Health Companies Inc. or its affiliates

Rev. 01/2020

Made in Canada

PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Caladryl ®

Topical Analgesic ∙ Skin Protectant
Lotion

Calamine PlusItch Reliever

6 FL OZ (177 mL)

label.jpg
label.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1234533Caladryl 8 % / 1 % Topical LotionPSN6
1234532calamine 8 % / pramoxine HCl 1 % Topical LotionPSN6
1234533calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Lotion [Caladryl]SBD6
1234532calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical LotionSCD6
1234533Caladryl (calamine 8 % / pramoxine hydrochloride 1 % ) Topical LotionSY6
1234532calamine 8 % / pramoxine hydrochloride 1 % Topical LotionSY6

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0187-5465-06Caladryl177 mL in 1 BOTTLE, PLASTICLOTION1776

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0187-5465CALADRYL (FERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDE) LOTION [BAUSCH HEALTH US, LLC]6Current NDC, Legacy NDC, 1 package rows20241019_67d4fd42-9fed-4238-9f5a-c9403abbcf20.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0187-5465-06ML - Milliliter0187-5465d7d2d28a-6ac7-4ac3-9b48-8cb69f309c7312015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Ferric Oxide RedACTIVE INGREDIENT1K09F3G6751
Pramoxine HydrochlorideACTIVE INGREDIENT88AYB867L51
Zinc OxideACTIVE INGREDIENTSOI2LOH54Z1
Ferric Oxide RedACTIVE MOIETY1K09F3G6751
PramoxineACTIVE MOIETY068X84E0561
Zinc OxideACTIVE MOIETYSOI2LOH54Z1
Camphor (Synthetic)INACTIVE INGREDIENT5TJD82A1ET1
Diazolidinyl UreaINACTIVE INGREDIENTH5RIZ3MPW41
HypromellosesINACTIVE INGREDIENT3NXW29V3WO1
MethylparabenINACTIVE INGREDIENTA2I8C7HI9T1
Polysorbate 80INACTIVE INGREDIENT6OZP39ZG8H1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V31
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OH1
WaterINACTIVE INGREDIENT059QF0KO0R1
Xanthan GumINACTIVE INGREDIENTTTV12P4NEE1

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
0187-54650187-5465-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAMPHOR (SYNTHETIC)5TJD82A1ETIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
METHYLPARABENA2I8C7HI9TIACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
XANTHAN GUMTTV12P4NEEIACT
FERRIC OXIDE RED1K09F3G675ACTIB
ZINC OXIDESOI2LOH54ZACTIB
PRAMOXINE HYDROCHLORIDE88AYB867L5ACTIB

Source Document#

Source XML · Source PDF

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 · 18 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Polysorbate 80POLYSORBATE 806OZP39ZG8HLOTION / TOPICAL15 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Camphor (Synthetic)CAMPHOR (SYNTHETIC)5TJD82A1ETDROPS / OPHTHALMICNAExact identifier — unii candidate
4 equally ranked IID candidates
Polysorbate 80POLYSORBATE 806OZP39ZG8HLOTION / TOPICAL15 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Camphor (Synthetic)CAMPHOR (SYNTHETIC)5TJD82A1ETDROPS / OPHTHALMICNAExact identifier — unii candidate
4 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEELOTION / TOPICAL0.3 %w/vExact 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
Xanthan GumXANTHAN GUMTTV12P4NEELOTION / TOPICAL0.3 %w/vExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Camphor (Synthetic)CAMPHOR (SYNTHETIC)5TJD82A1ETJELLY / NASAL65 mgExact identifier — unii candidate
4 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHLOTION / TOPICAL140 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Camphor (Synthetic)CAMPHOR (SYNTHETIC)5TJD82A1ETJELLY / NASAL65 mgExact identifier — unii candidate
4 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TLOTION / TOPICAL351 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3LOTION / TOPICAL3392 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
HypromellosesHYPROMELLOSE3NXW29V3WOLOTION / TOPICAL0.1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
HypromellosesHYPROMELLOSE3NXW29V3WOLOTION / TOPICAL0.1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TLOTION / TOPICAL351 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
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3LOTION / TOPICAL3392 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHLOTION / TOPICAL140 mgExact identifier — unii+route+dosage form
2 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
CaladrylFERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDEBausch Health US, LLC67d4fd42-9fed-4238-9f5a-c9403abbcf202024-10-17WarningsExact identifier
ndc (package): 0187-5465-06
ndc (product): 0187-5465
ndc11 (package): 00187546506
spl id: 24add3ce-a1f0-0b6a-e063-6394a90a77c2
spl set id: 67d4fd42-9fed-4238-9f5a-c9403abbcf20

Reported adverse events (FAERS/openFDA)#

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