FDA.reportPublic FDA data

Good Sense 336.003/336AG Medicated Calamine Lotion

Manufacturer
Consumer Product Partners, LLC
Effective date
2024-03-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:08:53

Label at a glance#

ProductCalamine
Active ingredientFERRIC OXIDE RED, PRAMOXINE HYDROCHLORIDE
Label structure13 sections

Indications and uses

for the temporary relief of pain and itching associated with minot skin irritations and rashes due to poison ivy, poison oak, or poison sumac dries the oozing and weeping of poison: -ivy -oak -sumac

Dosage and administration

shake well before applying was affected are of skin 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 - do not use, ask a doctor

Storage and handling

store at room temperature (59°-77°F)

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Calamine 8%

Pramoxine HCl 1%

Purpose

OTC - PURPOSE SECTION

Skin protectant

External analgesic

Uses

INDICATIONS & USAGE SECTION

  • for the temporary relief of pain and itching associated with minot skin irritations and rashes due to poison ivy, poison oak, or poison sumac
  • dries the oozing and weeping of poison: -ivy -oak -sumac

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • do not get into eyes

Stop use and ask a doctor if 

OTC - STOP USE SECTION

  • condition worsens
  • symptoms last more than 7 days or clean up and occur again within a few days

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well
  • before applying was affected are of skin

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 - do not use, ask a doctor

Other information

STORAGE AND HANDLING SECTION

store at room temperature (59°-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

alcohol, benzyl alcohol, camphor, fragrance, hydroxypropyl methylcellulose, Lavandula angustifolia (lavender) oil, phenoxyethanol, polysorbate 80, propylene glycol, Rosmarinus officinalis (rosemary) leaf oil, water, xanthan gum

Disclaimer

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by Bausch Health US, LLC, distributor of Caladryl Lotion Calamine Plus Itch Reliever.

Adverse reaction

ADVERSE REACTIONS SECTION

Distributed by Perrigo Direct, Inc.

Peachtree City, GA 30269

www.PerrigoDirect.com

1-888-593-0593

Good Sense is a registered trademark of L. Perrigo Company

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 11344-336-30

GoodSense

MEDICATED

Calamine Itch Relief Lotion

EXTERNAL ANALGESIC/SKIN PROTECTANT

Pain and itch reliever

Compare to active ingredients of Caladryl Lotion*

6 FL OZ (177 mL)

image descriptionimage description

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11344-336CALAMINE (CALAMINE, PRAMOXIND HCL) LOTION [CONSUMER PRODUCT PARTNERS, LLC]3Legacy NDC20240314_482898e5-ec45-4582-b61b-cedc1ed32a92.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11344-336-30ML - Milliliter11344-336cb6a3979-939f-4690-9a3c-558664ae957512022-09-12

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11344-33611344-336-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
BENZYL ALCOHOLLKG8494WBHIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
LAVENDER OILZBP1YXW0H8IACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ROSEMARY OIL8LGU7VM393IACT
WATER059QF0KO0RIACT
XANTHAN GUMTTV12P4NEEIACT
FERRIC OXIDE RED1K09F3G675ACTIB
PRAMOXINE HYDROCHLORIDE88AYB867L5ACTIB

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
38029d37-f03f-3344-e063-6394a90ad68b482898e5-ec45-4582-b61b-cedc1ed32a922025-06-20Warnings, Adverse reactionsExact identifier
spl set id: 482898e5-ec45-4582-b61b-cedc1ed32a92

Reported adverse events (FAERS/openFDA)#

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