FDA.reportPublic FDA data

Premier Solutions Calamine Plus Spray

Manufacturer
Premier Brands of America Inc.
Effective date
2025-11-03
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:41:52

Label at a glance#

ProductCalamine Plus Pramoxine HCl
Active ingredientFERRIC OXIDE RED, ZINC OXIDE, PRAMOXINE HYDROCHLORIDE
Label structure10 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 to 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:

OTHER SAFETY INFORMATION

Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F. Intentional misuse by deliberately concentrating and inhailing 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
  • 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 to 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

RECENT MAJOR CHANGES SECTION

.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Premier

solutions


NO-RUB
CALAMINE

PLUS SPRAY

CALAMINE 8% / SKIN PROTECTANT
PRAMOXINE HCL 1% / EXTERNAL ANALGESIC

RELIEVES ITCHING FROM

POISON IVY, OAK & SUMAC,
PLUS INSECT BITES

Soothes minor skin irritations & cuts


SHAKE WELL!


NET WT. 4.1 OZ. (116g)

cartoncarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1544717calamine 8 % / pramoxine HCl 1 % Topical SprayPSN3
1544717calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical SpraySCD3
1544717calamine 8 % / pramoxine hydrochloride 1 % Topical SpraySY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
56104-100-10Calamine Plus Pramoxine HCl116 g in 1 CANAEROSOL, SPRAY1163

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
56104-10056104-100-10

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

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22025-05-30full-release2026-06-01 01:01:58

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
Calamine Plus Pramoxine HClCALAMINE PLUS NO TOUCH SPRAYPremier Brands of America Inc.36481d67-2346-470b-e063-6294a90aae992025-11-03WarningsExact identifier
ndc (package): 56104-100-10
ndc (product): 56104-100
ndc11 (package): 56104010010
spl id: 42b813fe-1a86-a199-e063-6394a90a1eff
spl set id: 36481d67-2346-470b-e063-6294a90aae99

Reported adverse events (FAERS/openFDA)#

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