FDA.reportPublic FDA data

Good Sense 218.002/218AF Clear Anti-Itch Lotion

Manufacturer
Perrigo Direct, Inc | Nice-Pak Products, LLC
Effective date
2026-02-19
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:46:42

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

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

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

Disclaimer

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by Bausch Health US, LLC, distributor of Caladryl ® Clear ® Lotion.

Adverse reaction

ADVERSE REACTIONS SECTION

Distributed by: Perrigo Direct, Inc.

Peachtree City, GA 30269

www.PerrigoDirect.com

1-888-593-0593

GoodSense ®is a registered trademark of L. Perrigo Company.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 75981-218-30

GoodSENSE ®

Clear Anti-Itch Lotion

External Analgesic/Skin Protectant

Pain and Itch Reliever

Compare to active ingredients of Caladryl ® Clear ® Lotion*

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 LotionPSN5
1234546pramoxine hydrochloride 10 MG/ML / zinc acetate 1 MG/ML Topical LotionSCD5
1234546pramoxine HCl 1 % / zinc acetate 0.1 % Topical LotionSY5

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
Data codeData MatrixL0002470SDmm01.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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
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
75981-218-30Clear Anti-Itch177 mL in 1 BOTTLE, PLASTICLOTION1775

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
75981-21875981-218-30

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 ACETATEPerrigo Direct, Inccc0378f2-6d5f-47ec-b16a-64668b4c29cc2026-02-19Warnings, Adverse reactionsExact identifier
ndc (package): 75981-218-30
ndc (product): 75981-218
ndc11 (package): 75981021830
spl id: 4b30e9a2-0f28-15ba-e063-6394a90aaa7a
spl set id: cc0378f2-6d5f-47ec-b16a-64668b4c29cc

Reported adverse events (FAERS/openFDA)#

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