CeraVe Itch Relief Moisturizing

Manufacturer
VALEANT PHARMACEUTICALS NORTH AMERICA LLC | Accupac, Inc.
Effective date
2016-02-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:28:13

Label at a glance#

ProductCeraVe Itch Relief Moisturizing Cream
Active ingredientPRAMOXINE HYDROCHLORIDE
Label structure7 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

SPL UNCLASSIFIED 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, glycerin, petrolatum, cetyl alcohol, stearic acid, butyrospermum parkii (shea) butter, cetearyl alcohol, isopropyl myristate, glyceryl stearate, PEG-100 stearate, dimethicone, ceramide 3, ceramide 6-II, ceramide 1, hyaluronic acid, phenoxyethanol, behentrimonium methosulphate, xanthan gum, sodium hydroxide, alcohol denat., ethylhexylglycerin, sodium lauroyl lactylate, disodium EDTA, potassium phosphate, dipotassium phosphate, tasmannia lanceolata fruit exact, phytosphingosine, cholesterol, carbomer

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW

CeraVe®

DEVELOPED WITH DERMATOLOGISTS

Itch Relief

Moisturizing Cream

PRAMOXINE HYDROCHLORIDE 1%

STEROID FREE

Relieves itch and

irritation from:

[icon – check mark] Dry skin

[icon – check mark] Insect bites

[icon – check mark] Sunburn

[icon - National Eczema Association Seal]

With ceramides

Net Wt. 12 OZ (340 g)

CeraVe Itch Relief Moisturizing Cream 12 OZ Jar Label.jpg
CeraVe Itch Relief Moisturizing Cream 12 OZ Jar Label.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0187-1975-122021-05-06C16284748780-19d75b9d0-5ede-f424-e053-dadaa90a57ceDrug Facts
0187-1975-122020-01-31C16284748780-19d75b9d0-5ede-f424-e053-dadaa90a57ceDrug Facts

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0187-19750187-1975-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

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
379b19f9-9a39-42e8-bf51-2159101832f3a4f3e54b-220c-48dc-8ef8-91d88c384bf92016-02-22WarningsExact identifier
spl set id: a4f3e54b-220c-48dc-8ef8-91d88c384bf9

Reported adverse events (FAERS/openFDA)#

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