FDA.reportPublic FDA data

Calamine Plus Spray

Manufacturer
HY-VEE, INC
Effective date
2017-12-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:53:37

Label at a glance#

ProductCalamine Plus Pramoxine HCl
Active ingredientFERRIC OXIDE RED, ZINC OXIDE, PRAMOXINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

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

Dosage and administration

shake well before using adults and children 2 years of age and older: apply as needed to the affected area, not more than 3 or 4 times daily cleanse the skin with soap and water let dry before use children under 2 years of age: consult a doctor

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Calamine 8%
Pramoxine HCl 1%

Purpose

OTC - PURPOSE SECTION

Skin protectant
External analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves pain and itching associated with:

  • insect bites
  • rashes
  • minor skin irritations
  • minor cuts
  • dries the oozing and weeping of poison ivy, poison oak and poison sumac

Warnings

WARNINGS SECTION

For external use only. Use only as directed. Intentional misuse by deliberately concentrating and inhailing contents can be harmful or fatal.

When using this product

OTHER SAFETY INFORMATION

  • do not get into eyes
  • ask a doctor before using on children under 2 years of age

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • conditions worsens
  • symtomps last more than 7 days or clear up and occur again in 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 using
  • adults and children 2 years of age and older: apply as needed to the affected area, not more than 3 or 4 times daily
  • cleanse the skin with soap and water
  • let dry before use
  • children under 2 years of age: consult a doctor

Other information

OTHER SAFETY INFORMATION

store between 20° to 25°C (68° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzyl alcohol, camphor, disteardimonium hectorite, fragrance, hydrated silica, isobutane, oleyl alcohol, SD alcohol 40-B, sorbitan trioleate

Questions?

OTC - QUESTIONS SECTION

Call 1-866-964-0939

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HyVee Health 

Calamine Plan Spray

Calamine 8% - Skin Protectant

Promoxine HCL 1% - External Analgesic

Drying action plus itch relief

Ideal for: poison ivy/ oak/ sumac

insect bites, minor skin irritations & cuts

SHAKE WELL BEFORE USE

NET WT 4.1 OZ (116 g)

Hyvee_Calamine Spray_50-074HY-01.jpgHyvee_Calamine Spray_50-074HY-01.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1544717calamine 8 % / pramoxine HCl 1 % Topical SprayPSN1
1544717calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical SpraySCD1
1544717calamine 8 % / pramoxine hydrochloride 1 % Topical SpraySY1

DailyMed Pharmacologic Classes#

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

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
42507-147-412021-07-23C16284748780-1c7ccaba7-1941-fd44-e053-dadaa90aa01bCalamine Plus Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42507-147-41Calamine Plus Pramoxine HCl116 g in 1 CANISTERAEROSOL, SPRAY1161

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42507-147CALAMINE PLUS PRAMOXINE HCL (CALAMINE PLUS SPRAY) AEROSOL, SPRAY [HY-VEE, INC]1Legacy NDC, 1 package rows20171222_7a5475ae-f2df-4bbe-aca1-635f719a088a.zip

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
42507-14742507-147-41

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
FERRIC OXIDE RED1K09F3G675ACTIB
ZINC OXIDESOI2LOH54ZACTIM
PRAMOXINE HYDROCHLORIDE88AYB867L5ACTIB
BENZYL ALCOHOLLKG8494WBHIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
HYDRATED SILICAY6O7T4G8P9IACT
ISOBUTANEBXR49TP611IACT
OLEYL ALCOHOL172F2WN8DVIACT
ALCOHOL3K9958V90MIACT
SORBITAN TRIOLEATEQE6F49RPJ1IACT

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
4ba77efb-690f-4e52-8907-fa2d9159052f7a5475ae-f2df-4bbe-aca1-635f719a088a2017-12-22WarningsExact identifier
spl id: 4ba77efb-690f-4e52-8907-fa2d9159052f
spl set id: 7a5475ae-f2df-4bbe-aca1-635f719a088a

Reported adverse events (FAERS/openFDA)#

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