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Drug Facts

Manufacturer
L'Oreal USA Products Inc | L'Oreal USA Products, Inc.
Effective date
2026-05-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:58:06

Label at a glance#

ProductCeraVe Developed with Dermatologists Itch Relief Moisturizing
Active ingredientPRAMOXINE HYDROCHLORIDE
Label structure10 sections

Dosage and administration

• Adults and children 2 years of age and older:    • apply to affected area not more than 3 to 4 times daily • for use on children 2–12 years old, application should be supervised by an adult

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Pramoxine hydrochloride 1%

Purpose

OTC - PURPOSE SECTION

Topical antipruritic

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

if you are allergic to any of the ingredients.

When using this product,

OTC - WHEN USING SECTION

avoid contact with eyes. If contact occurs, rinse with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

• condition worsens

• symptoms last more than 7 days or reoccur 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 Poison Control Centre immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

• Adults and children 2 years of age and older:

   • apply to affected area not more than 3 to 4 times daily

• for use on children 2–12 years old, application should be supervised by an adult

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua, Glycerin, Petrolatum, Cetyl alcohol, Butyrospermum parkii (shea) butter, Cetearyl alcohol, Glyceryl stearate, PEG-100 stearate, Isopropyl
myristate, Stearic acid, Dimethicone, Palmitic acid, Phenoxyethanol, Behentrimonium methosulfate, Xanthan gum, Sodium hydroxide,
Ethylhexylglycerin, Myristic acid, Sodium lauroyl lactylate, Potassium phosphate, Dipotassium phosphate, Disodium EDTA, Tasmannia lanceolata
fruit/leaf extract, Ceramide NP, Ceramide AP, Phytosphingosine, Cholesterol, Carbomer, Hydrolyzed hyaluronic acid, Citric acid, Ceramide EOP.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

jar frontjar frontjar backjar back

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1052684pramoxine HCl 1 % Topical CreamPSN1
1052684pramoxine hydrochloride 10 MG/ML Topical CreamSCD1
1052684pramoxine hydrochloride 1 % Topical CreamSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
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
82046-034-01CeraVe Developed with Dermatologists Itch Relief Moisturizing340 g in 1 JARCREAM3401

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82046-03482046-034-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
PETROLATUM4T6H12BN9UIACT
CETYL ALCOHOL936JST6JCNIACT
SHEA BUTTERK49155WL9YIACT
CETEARYL ALCOHOL2DMT128M1SIACT
GLYCERYL STEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
STEARIC ACID4ELV7Z65APIACT
DIMETHICONE92RU3N3Y1OIACT
PALMITIC ACID2V16EO95H1IACT
PHENOXYETHANOLHIE492ZZ3TIACT
BEHENTRIMONIUM METHOSULFATE5SHP745C61IACT
XANTHAN GUMTTV12P4NEEIACT
SODIUM HYDROXIDE55X04QC32IIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
MYRISTIC ACID0I3V7S25AWIACT
SODIUM LAUROYL LACTYLATE7243K85WFOIACT
POTASSIUM PHOSPHATEB7862WZ632IACT
DIBASIC POTASSIUM PHOSPHATECI71S98N1ZIACT
EDETATE SODIUMMP1J8420LUIACT
TASMANNIA LANCEOLATA FRUITPNT2HDL13QIACT
CERAMIDE NP4370DF050BIACT
CERAMIDE APF1X8L2B00JIACT
PHYTOSPHINGOSINEGIN46U9Q2QIACT
CHOLESTEROL97C5T2UQ7JIACT
CARBOMER0A5MM307FCIACT
HYALURONIC ACIDS270N0TRQYIACT
CITRIC ACID2968PHW8QPIACT
PRAMOXINE HYDROCHLORIDE88AYB867L5ACTIB

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
522e7455-2817-b1c0-e063-6394a90a8de64c396286-fffe-420d-ba94-91fb73f04a692026-05-19WarningsExact identifier
spl id: 522e7455-2817-b1c0-e063-6394a90a8de6
spl set id: 4c396286-fffe-420d-ba94-91fb73f04a69

Reported adverse events (FAERS/openFDA)#

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