FDA.reportPublic FDA data

Drug Facts

Manufacturer
L'Oreal USA Products Inc | L'OREAL USA PRODUCTS, INC | L'Oreal USA, Inc. | Accupac, LLC
Effective date
2026-05-12
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:57:07

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 Children under 2 years of age: consult a doctor

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Pramoxine hydrochloride 1%

Purpose

OTC - PURPOSE SECTION

External analgesic

Use

INDICATIONS & USAGE SECTION

For the temporary relief of itching associated with minor skin irritations

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

do not get into eyes

Stop use 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
Do not use on

OTC - DO NOT USE SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns

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 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

Children under 2 years of age: consult a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, isopropyl myristate, PEG-100 stearate, glyceryl stearate, cetearyl alcohol, cetyl alcohol, glycerin, niacinamide, dimethicone, stearic acid, allantoin, potassium phosphate, ceramide NP, ceramide AP, ceramide EOP, carbomer, zinc citrate, behentrimonium methosulfate, sodium hydroxide, sodium lauroyl lactylate, arginine PCA, myristic acid, sodium PCA, cholesterol, palmitic acid, tasmannia lanceolata fruit extract, phenoxyethanol, dipotassium phosphate, disodium EDTA, alcohol denat., tocopheryl acetate, hydrolyzed hyaluronic acid, xanthan gum, phytosphingosine, polyglyceryl-3 diisostearate, ethylhexylglycerin

Questions?

OTC - QUESTIONS SECTION

Toll-Free Number 888-768-2915

www.cerave.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of a front labelimage of a front labelimage of a front labelimage of a front label

image of a front label
image of a front label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of a back labelimage of a back labelimage of a back labelimage of a back label

image of a back label
image of a back label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cartoncartonfrontfrontbackback

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-133606000544017GTIN-13: 3606000544017
EAN-13: 3606000544017
GTIN storage (14 digits): 03606000544017		CVItchReliefLotionBack.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
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
49967-970-01CeraVe Developed with Dermatologists Itch Relief Moisturizing237 mL in 1 BOTTLE, PUMPLOTION2379
49967-970-02CeraVe Developed with Dermatologists Itch Relief Moisturizing15 in 1 TRAYLOTION159
49967-970-02CeraVe Developed with Dermatologists Itch Relief Moisturizing29.6 mL in 1 BOTTLELOTION29.69
49967-970-03CeraVe Developed with Dermatologists Itch Relief Moisturizing473 mL in 1 BOTTLELOTION4739
49967-970-04CeraVe Developed with Dermatologists Itch Relief Moisturizing562 mL in 1 BOTTLELOTION5629

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49967-970-01ML - Milliliter49967-970b98df13a-1797-40e8-b0d2-71f8aa29744c12021-12-08

Products#

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

DailyMed product names page 1 of 1 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49967-97049967-970-01, 49967-970-02, 49967-970-03, 49967-970-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

Name, UNII, Kind table
NameUNIIKind
PRAMOXINE HYDROCHLORIDE88AYB867L5ACTIB
WATER059QF0KO0RIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
CETYL ALCOHOL936JST6JCNIACT
STEARIC ACID4ELV7Z65APIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
GLYCERINPDC6A3C0OXIACT
DIMETHICONE92RU3N3Y1OIACT
NIACINAMIDE25X51I8RD4IACT
CERAMIDE 34370DF050BIACT
CERAMIDE 6 IIF1X8L2B00JIACT
CERAMIDE 15THT33P7X7IACT
PHENOXYETHANOLHIE492ZZ3TIACT
XANTHAN GUMTTV12P4NEEIACT
BEHENTRIMONIUM METHOSULFATE5SHP745C61IACT
POLYGLYCERYL-3 DIISOSTEARATE46P231IQV8IACT
SODIUM HYDROXIDE55X04QC32IIACT
ALLANTOIN344S277G0ZIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
SODIUM LAUROYL LACTYLATE7243K85WFOIACT
ARGININE PYROGLUTAMATE808T94CEU6IACT
EDETATE DISODIUM7FLD91C86KIACT
POTASSIUM PHOSPHATE, MONOBASIC4J9FJ0HL51IACT
POTASSIUM PHOSPHATE, DIBASICCI71S98N1ZIACT
ZINC CITRATEK72I3DEX9BIACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
PHYTOSPHINGOSINEGIN46U9Q2QIACT
CHOLESTEROL97C5T2UQ7JIACT
MYRISTIC ACID0I3V7S25AWIACT
PALMITIC ACID2V16EO95H1IACT
HYALURONIC ACIDS270N0TRQYIACT
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)F68VH75CJCIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT

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
CeraVe Developed with Dermatologists Itch Relief MoisturizingPRAMOXINE HYDROCHLORIDEL'Oreal USA Products Inc13ce57d0-b1c5-4685-ad7d-a562d9d8fc862026-05-12WarningsExact identifier
ndc (package): 49967-970-04
ndc (package): 49967-970-01
ndc (package): 49967-970-02
ndc (package): 49967-970-03
ndc (product): 49967-970
ndc11 (package): 49967097003
ndc11 (package): 49967097001
ndc11 (package): 49967097002
ndc11 (package): 49967097004
spl id: ea7e8fa8-1b1c-46e5-88e5-b6a5f853ffc8
spl set id: 13ce57d0-b1c5-4685-ad7d-a562d9d8fc86

Reported adverse events (FAERS/openFDA)#

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