CERAVE DEVELOPED WITH DERMATOLOGISTS ANTI ITCH- hydrocortisone cream 
L'Oreal USA Products Inc.

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 uses

for the treatment of diaper rash. Consult a doctor.

When using this product

avoid contact with the eyes

Stop use and ask a doctor if

if condition worsens or if 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 consulted 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, glycerin, ceteareth-20, isopropyl myristate, cyclopentasiloxane, benzyl alcohol, isostearyl neopentanoate, cetyl palmitate, PEG-40 stearate,. potassium lactate, ceramide NP, ceramide AP, potassium sorbate,. ceramide EOP, carbomer, niacinamide, dimethicone/vinyltrimethylsiloxysilicate crosspolymer, dimethyl MEA, aloe barbadensis leaf juice, methylparaben, sodium lauroyl lactylate, sodium hyaluronate, sodium benzoate, cholesterol, avena sativa (oat) kernel extract, phenoxyethanol, citric acid, phytosphingosine, xanthan gum, maltodextrin, chrysanthemum parthenium (feverfew) extract, ethylhexylglycerin

Other information

store at 20° to 25°C (68° to 77°F)

Questions

Toll-free number 1-888-768-2915

www.CeraVe.com

image of a carton

CERAVE DEVELOPED WITH DERMATOLOGISTS ANTI ITCH 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-108
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)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
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)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
TANACETUM PARTHENIUM (UNII: 6GE7Z0761K)  
CERAMIDE 3 (UNII: 4370DF050B)  
CERAMIDE 6 II (UNII: F1X8L2B00J)  
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
XANTHAN GUM (UNII: TTV12P4NEE)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CERAMIDE 1 (UNII: 5THT33P7X7)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-108-011 in 1 CARTON11/14/2017
128 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:49967-108-0214 g in 1 TUBE; Type 0: Not a Combination Product11/14/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/14/2017
Labeler - L'Oreal USA Products Inc. (002136794)
Establishment
NameAddressID/FEIBusiness Operations
Accupac, Inc071609663MANUFACTURE(49967-108)

Revised: 7/2023
 
L'Oreal USA Products Inc.