FDA.reportPublic FDA data

CareOne Calamine Plus Spray

Manufacturer
Foodhold USA
Effective date
2024-11-07
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:35:40

Label at a glance#

ProductCalamine Plus Pramoxine HCl
Active ingredientZINC OXIDE, PRAMOXINE HYDROCHLORIDE, FERRIC OXIDE RED
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.

Flammable:

SPL INDEXING DATA ELEMENTS SECTION

Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120ºF. Intentional misuse by delibrately concentrating and inhaling contents can be harmful or fatal.

When using this product

OTC - WHEN USING SECTION

  • 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
  • symptoms 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

CareOne

NO-RUB CALAMINE SPRAY

Calamine 8%/ Skin Protectant

Pramoxine HCl 1%/ External Analgesic

TEMPORARILY RELIEVES ITCHING FROM POISON IVY, OAK & SUMAC, AND INSECT BITES

SOOTHES MINOR SKIN IRRITATIONS AND CUTS

Shake well before use

NET WT 4.1 OZ (116g)

Calamine Plus SprayCalamine Plus Spray

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1544717calamine 8 % / pramoxine HCl 1 % Topical SprayPSN5
1544717calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical SpraySCD5
1544717calamine 8 % / pramoxine hydrochloride 1 % Topical SpraySY5

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
41520-184-412023-01-12C16284748780-1c7ccaba7-199e-fd44-e053-dadaa90aa01bCareOne Calamine Plus Spray
41520-184-412021-07-23C16284748780-1c7ccaba7-199e-fd44-e053-dadaa90aa01bCareOne Calamine Plus Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41520-184-41Calamine Plus Pramoxine HCl116 g in 1 CANISTERAEROSOL, SPRAY1165

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-184CALAMINE PLUS PRAMOXINE HCL (CALAMINE PLUS SPRAY) AEROSOL, SPRAY [FOODHOLD USA]5Legacy NDC, 1 package rows20241109_7cad7ad7-347a-6992-e053-2a91aa0a9ad6.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41520-18441520-184-41

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
HYDRATED SILICAY6O7T4G8P9IACT
OLEYL ALCOHOL172F2WN8DVIACT
ALCOHOL3K9958V90MIACT
SORBITAN TRIOLEATEQE6F49RPJ1IACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
ISOBUTANEBXR49TP611IACT
BENZYL ALCOHOLLKG8494WBHIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETIACT
ZINC OXIDESOI2LOH54ZACTIB
PRAMOXINE HYDROCHLORIDE88AYB867L5ACTIB
FERRIC OXIDE RED1K09F3G675ACTIB

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
2655b5d8-7d21-011b-e063-6394a90ad4757cad7ad7-347a-6992-e053-2a91aa0a9ad62024-11-07WarningsExact identifier
spl id: 2655b5d8-7d21-011b-e063-6394a90ad475
spl set id: 7cad7ad7-347a-6992-e053-2a91aa0a9ad6

Reported adverse events (FAERS/openFDA)#

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