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CeraVe Anti-Itch

Dosage form: cream
Ingredients: HYDROCORTISONE 10mg in 1g
Labeler: Valeant Pharmaceuticals North America LLC
NDC Code: 0187-2486

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses
temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to: eczema, soaps, detergents, cosmetics, seborrheic dermatitis, psoriasis.
other uses of this product should only be under the advice and supervision of a doctor.

Warnings

For external use only

do not use for the treatment of diaper rash, consult a doctor.
When using this product avoid contact with eyes.
Stop use and ask a doctor if condition worsens, symptoms persist for more than 7 days, or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product unless you have asked a doctor.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions
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: do not use, ask a doctor.

Inactive ingredients

water, cetearyl alcohol, ceteareth-20, glycerin, isopropyl myristate, cyclopentasiloxane, benzyl alcohol, cetyl palmitate, isostearyl neopentanoate, citric acid, potassium lactate, dimethicone/vinyltrimethylsiloxysilicate crosspolymer, dimethyl MEA, PEG-40 stearate,

methylparaben, aloe barbadensis (aloe vera) leaf juice, niacinamide, avena sativa (oat) kernel extract, sodium lauroyl lactylate, chrysanthemum parthenium (feverfew) extract, hyaluronic acid, sodium hydroxide, ceramide 3, ceramide 6 II, phytosphingosine, cholesterol, xanthan gum, carbomer, ceramide 1

Other information
store at 20° to 25°C (68° to 77°F)

Questions

Toll-free number 800-321-4576

www.CeraVe.com

Distributed by:

Valeant Consumer Products,

a Division of Valeant

Pharmaceuticals

North America LLC,

Bridgewater, NJ 08807

9389500 Rev. 04/14

VALEANT™

Consumer Products

Package/Label Principal Display Panel

NEW

CeraVe®

DEVELOPED WITH DERMATOLOGISTS

Hydrocortisone

Anti-Itch Cream

FOR RASHES DUE TO ECZEMA

Relieves itch flare-ups due

to extra dry skin and eczema

Longest lasting hydrocortisone

cream without a prescription

Helps repair & restore

protective skin barrier

With essential ceramides

Maximum strength

Fragrance free

Net WT. 1 OZ (28 g)

Package/Label Principal Display Panel

NEW

CeraVe®

DEVELOPED WITH DERMATOLOGISTS

Hydrocortisone

Anti-Itch Cream

For rashes due

to eczema

Net WT. 1 OZ (28 g)

CERAVE  ANTI-ITCH
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0187-2486
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
CETOSTEARYL ALCOHOL 
POLYOXYL 20 CETOSTEARYL ETHER 
GLYCERIN 
ISOPROPYL MYRISTATE 
CYCLOMETHICONE 5 
BENZYL ALCOHOL 
CETYL PALMITATE 
ISOSTEARYL NEOPENTANOATE 
CITRIC ACID MONOHYDRATE 
POTASSIUM LACTATE 
DEANOL 
PEG-40 STEARATE 
METHYLPARABEN 
ALOE VERA LEAF 
NIACINAMIDE 
OAT 
SODIUM LAUROYL LACTYLATE 
TANACETUM PARTHENIUM 
SODIUM HYDROXIDE 
CERAMIDE 3 
CERAMIDE 6 II 
PHYTOSPHINGOSINE 
CHOLESTEROL 
XANTHAN GUM 
CERAMIDE 1 
Packaging
#Item CodePackage Description
1NDC:0187-2486-101 TUBE in 1 CARTON
128 g in 1 TUBE
2NDC:0187-2486-0514 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/01/2014
Labeler - Valeant Pharmaceuticals North America LLC (042230623)
Establishment
NameAddressID/FEIOperations
Accupac, Inc071609663MANUFACTURE(0187-2486)

Revised: 02/2015
 
Valeant Pharmaceuticals North America LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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