FDA.reportPublic FDA data

Rexall 218.002/218AF Clear Itch Relief Lotion

Manufacturer
Old East Main Co. | Nice-Pak Products, LLC
Effective date
2026-03-02
Label type
HUMAN OTC DRUG LABEL
Version
13
Source
full-release
Hydrated at
2026-06-01 01:48:26

Label at a glance#

ProductClear Anti-Itch
Active ingredientPRAMOXINE HYDROCHLORIDE, ZINC ACETATE
Label structure12 sections

Indications and uses

for the temporary relief of pain and itching associated with minor skin irritations and rashes due to poison ivy, poison oak or poison sumac dries the oozing and weeping of poison: - ivy - oak - sumac

Dosage and administration

shake well before applying wash affected area of skin 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 - ask a doctor

Storage and handling

store at room temperature (59° - 77°F)

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Pramoxine HCl 1%

Zinc acetate 0.1%

Purpose

OTC - PURPOSE SECTION

External analgesic

Skin protectant

Uses

INDICATIONS & USAGE SECTION

  • for the temporary relief of pain and itching associated with minor skin irritations and rashes due to poison ivy, poison oak or poison sumac
  • dries the oozing and weeping of poison: - ivy - oak - sumac

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • do not get into eyes

Stop use section and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within 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 applying wash affected area of skin

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 - ask a doctor

Other information

STORAGE AND HANDLING SECTION

store at room temperature (59° - 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

alcohol, benzoic acid, camphor, citric acid, fragrance, glycerin, hydroxypropyl methylcellulose, Lavandula angustifolia (lavender) oil, polysorbate 40, Rosmarinus officinalis (rosemary) leaf oil, sodium citrate, water

Adverse reaction

ADVERSE REACTIONS SECTION

Visit us at: Rexall.com or call 1-866-4-REXALL

DISTRIBUTED BY OLD EAST MAIN CO.

100 Mission Ridge

Goodlettsville, TN 37072 

Since 1903 Rexall ®is a registered trademark of Rexall Sundown, Inc.

A0154

principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Since 1903

Rexall ®

Clear Anti-Itch Lotion

External Analgesic • Skin Protectant

For relief from pain and itching due  to:

  • Poison ivy, oak and sumac
  • Insect bites
  • Minor skin irritations

6 FL OZ (177 mL)

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1234546pramoxine HCl 1 % / zinc acetate 0.1 % Topical LotionPSN13
1234546pramoxine hydrochloride 10 MG/ML / zinc acetate 1 MG/ML Topical LotionSCD13
1234546pramoxine HCl 1 % / zinc acetate 0.1 % Topical LotionSY13

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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-218-30Clear Anti-Itch177 mL in 1 BOTTLE, PLASTICLOTION17713

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55910-21855910-218-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
BENZOIC ACID8SKN0B0MIMIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GLYCERINPDC6A3C0OXIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
LAVENDER OILZBP1YXW0H8IACT
POLYSORBATE 40STI11B5A2XIACT
ROSEMARY OIL8LGU7VM393IACT
SODIUM CITRATE1Q73Q2JULRIACT
WATER059QF0KO0RIACT
PRAMOXINE HYDROCHLORIDE88AYB867L5ACTIB
ZINC ACETATEFM5526K07AACTIB

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
Clear Anti-ItchPRAMOXINE HCL, ZINC ACETATEOld East Main Co.91df1434-bce6-4c6e-beee-cb5ec1cc8fff2026-03-02Warnings, Adverse reactionsExact identifier
ndc (package): 55910-218-30
ndc (product): 55910-218
ndc11 (package): 55910021830
spl id: 4c0f30d0-0ba1-5842-e063-6294a90aca18
spl set id: 91df1434-bce6-4c6e-beee-cb5ec1cc8fff

Reported adverse events (FAERS/openFDA)#

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