CERAVE ANTI-ITCH- hydrocortisone cream

CeraVe by

Drug Labeling and Warnings

CeraVe by is a Otc medication manufactured, distributed, or labeled by Valeant Pharmaceuticals North America LLC, Accupac, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

INGREDIENTS AND APPEARANCE

CERAVE  ANTI-ITCH
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0187-2486
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 3 (UNII: 4370DF050B)
CERAMIDE 6 II (UNII: F1X8L2B00J)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
CHOLESTEROL (UNII: 97C5T2UQ7J)
XANTHAN GUM (UNII: TTV12P4NEE)
CERAMIDE 1 (UNII: 5THT33P7X7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0187-2486-10	1 in 1 CARTON
1		28 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 0187-2486-05	14 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/01/2014

Labeler - Valeant Pharmaceuticals North America LLC (042230623)

Establishment
Name	Address	ID/FEI	Business Operations
Accupac, Inc		071609663	MANUFACTURE(0187-2486)