CeraVe Itch Relief Moisturizing

Manufacturer
VALEANT PHARMACEUTICALS NORTH AMERICA LLC | Accupac, Inc.
Effective date
2016-02-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:29:12

Label at a glance#

ProductCeraVe Itch Relief Moisturizing
Active ingredientPRAMOXINE HYDROCHLORIDE
Label structure8 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, isopropyl myristate, cetyl alcohol, stearic acid, cetearyl alcohol, glyceryl stearate, PEG-100 stearate, glycerin, dimethicone, niacinamide, ceramide 3, ceramide 6-II, ceramide 1, hyaluronic acid, phenoxyethanol, xanthan gum, behentrimoium methosulfate, polyglyceryl-3 diisostearate, sodium hydroxide, alcohol denat., allantoin, ethylhexylglycerin, sodium lauroyl lactylate, arginine PCA,

disodium EDTA, potassium phosphate, dipotassium phosphate, tasmannia lanceolata fruit extract, zinc citrate, sodium PCA, phytosphingosine, cholesterol, carbomer, tocopheryl acetate

Questions

OTC - QUESTIONS SECTION

Toll-Free Number 800-321-4576

www.cerave.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW

CeraVe®

DEVELOPED WITH DERMATOLOGISTS

Itch Relief

Moisturizing

Lotion

PRAMOXINE HYDROCHLORIDE 1%

Fast acting, long lasting

With ceramides

Relieves itch and irritation from:

[check mark icon] Dry skin

[check mark icon] Insect bites

[check mark icon] Sunburn

STEROID FREE

[icon - National Eczema Association Seal]

8 FL OZ (237 mL)

CeraVe Itch Relief Moisturizing Lotion 8 oz Labels.jpg
CeraVe Itch Relief Moisturizing Lotion 8 oz Labels.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0187-1970-082021-05-10C16284748780-19d75b9d1-0eb5-f424-e053-dadaa90a57ceDrug Facts
0187-1970-992021-05-10C16284748780-19d75b9d1-0eb5-f424-e053-dadaa90a57ceDrug Facts
0187-1970-082020-01-31C16284748780-19d75b9d1-0eb5-f424-e053-dadaa90a57ceDrug Facts
0187-1970-992020-01-31C16284748780-19d75b9d1-0eb5-f424-e053-dadaa90a57ceDrug Facts

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
0187-19700187-1970-08, 0187-1970-99

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 35 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
66f5504a-6f82-4b10-b3a1-73d2c7d078de5ed6ffe1-3acc-4c31-b315-9642d53e1a522016-02-05WarningsExact identifier
spl set id: 5ed6ffe1-3acc-4c31-b315-9642d53e1a52

Reported adverse events (FAERS/openFDA)#

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