FDA.reportPublic FDA data

Good Sense 336.003/336AG Medicated Calamine Lotion

Manufacturer
Perrigo Direct, Inc | Nice-Pak Products, LLC
Effective date
2026-02-19
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:46:37

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 minor 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 wash affected area 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 minor 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 clear 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 wash affected area 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 75981-336-30

GoodSense ®

Medicated Calamine 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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1234532calamine 8 % / pramoxine HCl 1 % Topical LotionPSN4
1234532calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical LotionSCD4
1234532calamine 8 % / pramoxine hydrochloride 1 % Topical LotionSY4

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
75981-336-30Calamine177 mL in 1 BOTTLE, PLASTICLOTION1774

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
75981-33675981-336-30

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
CalamineCALAMINE, PRAMOXIND HCLPerrigo Direct, Inc54a20ec9-ab86-4410-af94-e04393e9d4b32026-02-19Warnings, Adverse reactionsExact identifier
ndc (package): 75981-336-30
ndc (product): 75981-336
ndc11 (package): 75981033630
spl id: 4b312a63-f96b-3dcb-e063-6394a90a0815
spl set id: 54a20ec9-ab86-4410-af94-e04393e9d4b3

Reported adverse events (FAERS/openFDA)#

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