FDA.reportPublic FDA data

Caring Mills Calamine Plus Spray

Manufacturer
FSA Store Inc.
Effective date
2025-08-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:11:15

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 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 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

Compare to the active

ingredients in Caladryl Lotion

caring mill

No-Rub

Calamine

Plus Spray

Calamine 8% / Skin Protectant

Pramoxine HCL 1% / External Analgesic

  • Relieves itching from poison ivy,

oak & sumac, & insect bites

  • Soothes minor skin

irritations & cuts

Shake Well Before Use

NET WT. 4.1 OZ. (116 g)

cartoncarton

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
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
81522-959-01Calamine Plus Pramoxine HCl116 g in 1 CANAEROSOL, SPRAY1161

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
81522-95981522-959-01

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
BENZYL ALCOHOLLKG8494WBHIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETIACT
HYDRATED SILICAY6O7T4G8P9IACT
ISOBUTANEBXR49TP611IACT
OLEYL ALCOHOL172F2WN8DVIACT
SORBITAN TRIOLEATEQE6F49RPJ1IACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
ALCOHOL3K9958V90MIACT
FERRIC OXIDE RED1K09F3G675ACTIB
ZINC OXIDESOI2LOH54ZACTIM
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
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYFSA Store Inc.3cd18f96-34f7-3f2c-e063-6294a90a3b7e2025-08-19WarningsExact identifier
ndc (package): 81522-959-01
ndc (product): 81522-959
ndc11 (package): 81522095901
spl id: 3cd1933c-6340-50d6-e063-6294a90aca32
spl set id: 3cd18f96-34f7-3f2c-e063-6294a90a3b7e

Reported adverse events (FAERS/openFDA)#

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