FDA.reportPublic FDA data

Clear Itch Relief

Manufacturer
TopCare | Product Quest Mfg, LLC
Effective date
2018-06-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:56:03

Label at a glance#

ProductClear Itch Relief
Active ingredientPRAMOXINE HYDROCHLORIDE, ZINC ACETATE
Label structure6 sections

Indications and uses

Temporarily relieves pain and itching asociated with: rashes due to poison ivy, poison oak or poison sumac. insect bites. minor skin irritation. minor cuts. dries the oozing and weeping of poison ivy, poison oak and poison sumac.

Dosage and administration

shake well before use. 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: ask a doctor. 

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients                                                   Purpose
Pramoxine HCI 1.0%...............................................Topical analgesic
Zinc Acetate 0.1%.....................................................Skin protectant

Uses

INDICATIONS & USAGE SECTION

  • Temporarily relieves pain and itching asociated with:
  • rashes due to poison ivy, poison oak or poison sumac.
  • insect bites.
  • minor skin irritation.
  • minor cuts.
  • dries the oozing and weeping of poison ivy, poison oak and poison sumac.

Warnings

WARNINGS SECTION

For external use only.

Flammable: Do not use near heat, flame, or while smoking.

​​​

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. Rinse with water to remove.
  • Do not puncture or incinerate. Contents under pressure. Do no store at temperatures above 120F.

Stop use and ask a doctor if

OTC - ASK DOCTOR SECTION

  • condition worsens or does not improve within 7 days.
  • symptoms persist for more than 7 days or clear up and occur again with 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 use.
  • 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: ask a doctor. 

Inactive ingredients

INACTIVE INGREDIENT SECTION

Avena Sativa (Oat) Meal Extract,
Camphor, Citric Acid, Diazolidinyl Urea, Fragrance, Glycerin,
Hydroxypropyl Methylcellulose, Methylparaben, Polysorbate 40,
Propylene Glycol, Propylparaben, SD Alcohol 38-B, Sodium Citrate, Water.
CLEAR SKIN PROTECTANT
Pramoxine HCl 1% - Topical Analgesic
Zinc Acetate 0.1% - Skin Protectant
Drying Action PLUS Itch Relief
Continuous Spray
Relieves Pain And Itch
Associated Wit

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1294033pramoxine HCl 1 % / zinc acetate 0.1 % Topical SprayPSN1
1294033pramoxine hydrochloride 10 MG/ML / zinc acetate 1 MG/ML Topical SpraySCD1
1294033pramoxine HCl 1 % / zinc acetate 0.1 % Topical SpraySY1

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130036800381704GTIN-13: 0036800381704
EAN-13: 0036800381704
GTIN-12: 036800381704
UPC-A: 036800381704
GTIN storage (14 digits): 00036800381704		label.jpg

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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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
36800-874-032020-01-31C16284748780-19d75b9d0-d636-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-874-03Clear Itch Relief85 g in 1 CANSPRAY851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-874CLEAR ITCH RELIEF (PRAMOXINE HCL, ZINC ACETATE) SPRAY [TOPCARE]1Legacy NDC, 1 package rows20180625_3706db68-b671-4068-ba50-57849f66b83f.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-87436800-874-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
PRAMOXINE HYDROCHLORIDE88AYB867L5ACTIB
ZINC ACETATEFM5526K07AACTIB
ALCOHOL3K9958V90MIACT
OATMEAL8PI54V663YIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
GLYCERINPDC6A3C0OXIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
METHYLPARABENA2I8C7HI9TIACT
POLYSORBATE 40STI11B5A2XIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
SODIUM CITRATE1Q73Q2JULRIACT
WATER059QF0KO0RIACT

Source Document#

Source XML · Source PDF

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
d8e45abb-2fab-4e05-b436-18b7a8e400e23706db68-b671-4068-ba50-57849f66b83f2018-06-25WarningsExact identifier
spl id: d8e45abb-2fab-4e05-b436-18b7a8e400e2
spl set id: 3706db68-b671-4068-ba50-57849f66b83f

Reported adverse events (FAERS/openFDA)#

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