FDA.reportPublic FDA data

CVS Itch Relief

Manufacturer
CVS Pharmacy | Pharma Nobis, LLC
Effective date
2023-12-20
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:05:16

Label at a glance#

ProductCVS Itch Relief
Active ingredientPRAMOXINE HYDROCHLORIDE, ZINC ACETATE
Label structure9 sections

Dosage and administration

Adults and children 2 yrs. o f age and older . Shake well before using. Cleanse the skin with soap and water and let dry. Apply to the affected area using cotton or soft cloth not more than 3 to 4 times daily as needed for comfort. Children under 2 yrs. of age: Consult a doctor before use.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

CVS Itch Relief

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Pramoxine HCl 1%

Zinc Acetate 0.1%

Purpose

OTC - PURPOSE SECTION

External Analgesic

Skin Protectant

Use

INDICATIONS & USAGE SECTION

Dries the oozing and weeping, and temporarily relieves pain and itching of poison ivy, oak, and poison sumac and other minor skin irritations.

Warnings

WARNINGS SECTION

For external use only. Use only as directed. Avoid contact with eyes and mucous membranes, Ask doctor before using in children under 2 years of age.

Stop use and ask a doctor if 

OTC - STOP USE SECTION

condition worsens. Symptoms last for 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

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 2 yrs. of age and older. Shake well before using. Cleanse the skin with soap and water and let dry. Apply to the affected area using cotton or soft cloth not more than 3 to 4 times daily as needed for comfort.
  • Children under 2 yrs. of age: Consult a doctor before use.

Inactive Ingredient

INACTIVE INGREDIENT SECTION

  • SD Alcohol 38B 2.5%, Camphor, Diazolidinyl Urea, Fragrances, Glycerin, Hydroxypropyl Methylcellulose,  Methylparaben, Polysorbate 80, Propylene Glycol, Propylparaben, and Purified Water.

Other Information

OTHER SAFETY INFORMATION

  • store at room temperature 15 o – 30 oC (59 o – 85 oF)

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS CalaclearCVS CalaclearCVS Health

Itch Relief

CLEAR SKIN PROTECTANT

6 FL OZ (177 mL)

CVS Health Itch Relief CLEAR SKIN PROTECTANT 6 FL OZ (177 mL)CVS Health Itch Relief CLEAR SKIN PROTECTANT 6 FL OZ (177 mL)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1234546pramoxine HCl 1 % / zinc acetate 0.1 % Topical LotionPSN7
1234546pramoxine hydrochloride 10 MG/ML / zinc acetate 1 MG/ML Topical LotionSCD7
1234546pramoxine HCl 1 % / zinc acetate 0.1 % Topical LotionSY7

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-400-96CVS Itch Relief177 mL in 1 BOTTLE, PLASTICLOTION1777

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-400CVS ITCH RELIEF (PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE) LOTION [CVS PHARMACY]7Current NDC, Legacy NDC, 1 package rows20231221_c60cfbf2-6788-43dc-b23a-e3433b7f3265.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69842-400-96ML - Milliliter69842-400177b05ee-038b-426c-bc39-35fb63793cd712022-06-06

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-40069842-400-96

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
CAMPHOR (NATURAL)N20HL7Q941IACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
GLYCERINPDC6A3C0OXIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
METHYLPARABENA2I8C7HI9TIACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
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
CVS Itch ReliefPRAMOXINE HYDROCHLORIDE AND ZINC ACETATECVS Pharmacyc60cfbf2-6788-43dc-b23a-e3433b7f32652023-12-20WarningsExact identifier
ndc (package): 69842-400-96
ndc (product): 69842-400
ndc11 (package): 69842040096
spl id: 0cf95509-d4ee-83fb-e063-6394a90a4e08
spl set id: c60cfbf2-6788-43dc-b23a-e3433b7f3265

Reported adverse events (FAERS/openFDA)#

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