CERAVE ANTI-ITCH- hydrocortisone cream 
Bausch Health US LLC

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.

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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)

Hydrocortisone Cream Carton

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 Hydrocortisone 1 oz Cream carton
CERAVE  ANTI-ITCH
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0187-2486
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CETYL PALMITATE (UNII: 5ZA2S6B08X)  
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
POTASSIUM LACTATE (UNII: 87V1KMK4QV)  
DEANOL (UNII: 2N6K9DRA24)  
PEG-40 STEARATE (UNII: ECU18C66Q7)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
NIACINAMIDE (UNII: 25X51I8RD4)  
OAT (UNII: Z6J799EAJK)  
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
TANACETUM PARTHENIUM (UNII: 6GE7Z0761K)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
CERAMIDE NP (UNII: 4370DF050B)  
CERAMIDE AP (UNII: F1X8L2B00J)  
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CERAMIDE 1 (UNII: 5THT33P7X7)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0187-2486-101 in 1 CARTON12/01/201408/01/2017
128 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:0187-2486-0514 g in 1 TUBE; Type 0: Not a Combination Product12/01/201408/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/01/201408/01/2017
Labeler - Bausch Health US LLC (831922468)
Establishment
NameAddressID/FEIBusiness Operations
Accupac, Inc071609663MANUFACTURE(0187-2486)

Revised: 2/2015
 
Bausch Health US LLC