FDA.reportPublic FDA data

CVS Itch relief moisturizing Lotion

Manufacturer
CVS Health
Effective date
2023-10-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:56:59

Label at a glance#

ProductCVS Itch relief moisturizing
Active ingredientPRAMOXINE HYDROCHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Pramoxine Hydrochloride 1%

OTC - PURPOSE SECTION

External analgesic

INDICATIONS & USAGE SECTION

Use for the temporary relief of itching associated with minor skin irritations

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

do not get into eyes

OTC - STOP USE SECTION

Stop use and ask a doctor if

condition worsens

symptoms last more than 7 days or clear up and occur again within a few days

OTC - DO NOT USE SECTION

Do not use on

  • animal bites
  • severe puncture wounds or burns

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

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: Consult a doctor

INACTIVE INGREDIENT SECTION

Allantion, Aloe Vera, Arginine PCA, Behenic Acid, Ceramide AP, Ceramide EOP, Ceramide NP, Cetearyl Alcohol, Cetyl Alcohol, Cholesterol, Dimethicone, Disodium EDTA, Glycerin, Glyceryl Stearate, Isopropyl Palmitate, Niacinamide, PEG 100 Stearate, Isopropyl Palmitate, Niacinamide, PEG 100 Stearate, Phenoxyethanol, Phytosphingosine, Polyglyceryl-2- Diisostearate, polyglyceryl-6 Behenate, Polyglyceryl-10 Stearate, Potassium Sorbate, Purified water, Shea Butter, Sodium Cetearyl Sulfate, Sodium Levulinate, Sodium PCA, Stearic Acid, Tocopheryl Acetate, Triethanolamine, Triethyl Citrate, Xanthan Gum, Zinc Citrate.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label frontPackage Label frontPackage Label backPackage Label back

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1246075pramoxine HCl 1 % Topical LotionPSN2
1246075pramoxine hydrochloride 10 MG/ML Topical LotionSCD2
1246075pramoxine hydrochloride 1 % Topical LotionSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct 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
51316-144-01CVS Itch relief moisturizing237 mL in 1 BOTTLE, PUMPLOTION2372

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-144CVS ITCH RELIEF MOISTURIZING (PRAMOXINE HCL 1%) LOTION [CVS HEALTH]2Current NDC, 1 package rows20231019_f3a753fc-f448-6bba-e053-2a95a90a8e1b.zip

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51316-14451316-144-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHENOXYETHANOLHIE492ZZ3TIACT
CERAMIDE APF1X8L2B00JIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
POLYGLYCERYL-3 DISTEARATEZI1LK470XVIACT
TROLAMINE9O3K93S3TKIACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
XANTHAN GUMTTV12P4NEEIACT
ALOE VERA LEAFZY81Z83H0XIACT
CERAMIDE NP4370DF050BIACT
WATER059QF0KO0RIACT
SHEA BUTTERK49155WL9YIACT
PEG-100 STEARATEYD01N1999RIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
STEARIC ACID4ELV7Z65APIACT
NIACINAMIDE25X51I8RD4IACT
ZINC CITRATEK72I3DEX9BIACT
DIMETHICONE92RU3N3Y1OIACT
PRAMOXINE HYDROCHLORIDE88AYB867L5ACTIB
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
CETYL ALCOHOL936JST6JCNIACT
ALLANTOIN344S277G0ZIACT
ARGININE94ZLA3W45FIACT
CERAMIDE 15THT33P7X7IACT

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 relief moisturizingPRAMOXINE HCL 1%CVS Healthf3a753fc-f448-6bba-e053-2a95a90a8e1b2023-10-18WarningsExact identifier
ndc (package): 51316-144-01
ndc (product): 51316-144
ndc11 (package): 51316014401
spl id: 07da1e53-9830-4f91-e063-6394a90ae88e
spl set id: f3a753fc-f448-6bba-e053-2a95a90a8e1b

Reported adverse events (FAERS/openFDA)#

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