FDA.reportPublic FDA data

CVS Itch Relief Moisturizing Cream

Manufacturer
CVS
Effective date
2024-12-11
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:42:38

Label at a glance#

ProductPramoxine Itch relief
Active ingredientPRAMOXINE HYDROCHLORIDE
Label structure7 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Pramoxine Hydrochloride 1%

OTC - PURPOSE SECTION

External Analgesic

INDICATIONS & USAGE SECTION

For the temporary relief of itching associated with minor skin irritations

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

When using this product, do not get into eyes

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if

  • Condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days

OTC - DO NOT USE SECTION

Do not use on

  • deep or puncture wounds
  • animal bites
  • serious burns

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222)

DOSAGE & ADMINISTRATION SECTION

Directions:

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 : consult a doctor

INACTIVE INGREDIENT SECTION

Aloe Vera, Behenic Acid, Cetearyl Alcohol, Cetyl Alcohol, Ceramide AP, Ceramide EOP, Ceramide NP, Cholesterol, Dimethicone, Disodium EDTA, Glycerin, Glyceryl Stearate, Isopropyl Palmitate, PEG 100 Stearate, Petrolatum, Phenoxyethanol, Phystosphingosine, Polyglyceryl- 6 Behenate, Polyglyceryl-10 Stearate, Potassium Sorbate, Shea butter, Sodium Cetearyl Sulfate, Sodium Levulinate, Stearic Acid, Triethanolamine, Triethyl Citrate, Water, Xanthan Gum

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1052684pramoxine HCl 1 % Topical CreamPSN3
1052684pramoxine hydrochloride 10 MG/ML Topical CreamSCD3
1052684pramoxine hydrochloride 1 % Topical CreamSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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
51316-141-12Pramoxine Itch relief340 g in 1 JARCREAM3403

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-141PRAMOXINE ITCH RELIEF (PRAMOXINE HCL 1%) CREAM [CVS]3Current NDC, 1 package rows20241213_e947694c-c122-0291-e053-2995a90ac39a.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51316-14151316-141-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERYL STEARATE/PEG-100 STEARATERD25J5V947IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
EDETATE DISODIUM7FLD91C86KIACT
XANTHAN GUMTTV12P4NEEIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PRAMOXINE HYDROCHLORIDE88AYB867L5ACTIB
TROLAMINE9O3K93S3TKIACT
CHOLESTEROL97C5T2UQ7JIACT
DIMETHICONE92RU3N3Y1OIACT
ALOE VERA LEAFZY81Z83H0XIACT
CERAMIDE NP4370DF050BIACT
CERAMIDE 15THT33P7X7IACT
CETYL ALCOHOL936JST6JCNIACT
PETROLATUM4T6H12BN9UIACT
WHITE PETROLATUMB6E5W8RQJ4IACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
SHEA BUTTERK49155WL9YIACT
WATER059QF0KO0RIACT
CERAMIDE APF1X8L2B00JIACT
STEARIC ACID4ELV7Z65APIACT

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
Pramoxine Itch reliefPRAMOXINE HCL 1%CVSe947694c-c122-0291-e053-2995a90ac39a2024-12-11WarningsExact identifier
ndc (package): 51316-141-12
ndc (product): 51316-141
ndc11 (package): 51316014112
spl id: 28f13725-48d9-8774-e063-6394a90a6704
spl set id: e947694c-c122-0291-e053-2995a90ac39a

Reported adverse events (FAERS/openFDA)#

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