FDA.reportPublic FDA data

Quality Choice 336.003/336AG Medicated Calamine Lotion

Manufacturer
Chain Drug Marketing Association | Nice-Pak Products, LLC
Effective date
2026-02-27
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:47:52

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

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 CDMA, Inc.

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

SATISFACTION GUARANTEED

100% QC

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 83324-053-06

QC

QUALITY CHOICE

*Compare to CALADRYL

Medicated

Calamine

Lotion

External Analgesic/Skin Protectant

For relief from pain and itching due to:

Poison Ivy, Poison Sumac, Insect Bites, Poison Oak & Minor Skin Irritations

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 LotionPSN3
1234532calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical LotionSCD3
1234532calamine 8 % / pramoxine hydrochloride 1 % Topical LotionSY3

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeData MatrixL0022069SAmm01.jpg

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
83324-053-06Calamine177 mL in 1 BOTTLE, PLASTICLOTION1773

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83324-053-06ML - Milliliter83324-053533b1be6-53af-49e3-a19c-e445287293c612025-05-14

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
83324-05383324-053-06

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 (NATURAL)N20HL7Q941IACT
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, PRAMOXINE HCLChain Drug Marketing Association6c848b98-f01c-40f2-a9aa-2af76cb370c82026-02-27Warnings, Adverse reactionsExact identifier
ndc (package): 83324-053-06
ndc (product): 83324-053
ndc11 (package): 83324005306
spl id: 4bcf72e3-68ba-8e7d-e063-6294a90a7536
spl set id: 6c848b98-f01c-40f2-a9aa-2af76cb370c8

Reported adverse events (FAERS/openFDA)#

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