FDA.reportPublic FDA data

First Aid Clear Anti-Itch medicated pads

Manufacturer
Rite Aid | Product Quest Mfg, LLC
Effective date
2018-05-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:55:28

Label at a glance#

ProductFirst Aid Clear Anti-Itch medicated pads Rite Aid
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

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#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Pramoxine  HCl 1%               External Analgesic

Zinc Acetate 0.1%                 Skin Pretectant

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.

Stop use and ask a doctor if

OTC - ASK DOCTOR SECTION

  • condition worsens
  • 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

  • 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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2044805pramoxine HCl 1 % / zinc acetate 0.1 % Medicated PadPSN1
2044805pramoxine hydrochloride 10 MG/ML / zinc acetate 1 MG/ML Medicated PadSCD1
2044805pramoxine HCl 1 % / zinc acetate 0.1 % Medicated PadSY1

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
11822-7781-32020-01-31C16284748780-19d75b9d0-d501-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-7781-3First Aid Clear Anti-Itch medicated padsRite Aid69 g in 1 JARLIQUID691

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-7781FIRST AID CLEAR ANTI-ITCH MEDICATED PADS RITE AID (PRAMOXINE HCL, ZINC ACETATE) LIQUID [RITE AID]1Legacy NDC, 1 package rows20180509_c84d7d7b-6b6b-4b61-a92d-bf2bcd17b279.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
11822-778111822-7781-3

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

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
c83f0bfb-65c5-43b6-8937-504d1ff4fd5dc84d7d7b-6b6b-4b61-a92d-bf2bcd17b2792018-05-09WarningsExact identifier
spl id: c83f0bfb-65c5-43b6-8937-504d1ff4fd5d
spl set id: c84d7d7b-6b6b-4b61-a92d-bf2bcd17b279

Reported adverse events (FAERS/openFDA)#

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