Active Ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

temporarily relieves the itching and discomfort associated with minor skin irritations and rashes
other uses of this product should only be used 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
do not use more than directed unless told to do so by a doctor

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, and 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: ask a doctor

Inactive ingredients

water, glycerin, petrolatum, dimethicone, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, cetyl alcohol, glyceryl stearate, stearyl alcohol, isohexadecane, methyl gluceth-20, aloe barbadensis leaf juice, butyrospermum parkii (shea) butter extract, avena sativa (oat) kernel extract, zingiber officinale (ginger) root extract, boswellia serrata gum, bisabolol, ceramide NP, ceramide NS, ceramide EOS, ceramide EOP, ceramide AP, caprooyl phytosphingosine, caprooyl sphingosine, magnesium ascorbyl phosphate, tocopheryl acetate, maltodextrin, polysorbate 60, phenoxyethanol, disodium EDTA, dipropylene glycol, ceteareth-25, cholesterol, behenic acid, pentylene glycol, methylparaben, 4-t-butylcyclohexanol, citric acid, sodium citrate

PRINCIPAL DISPLAY PANEL

Cortizone 10®
MAXIMUM STRENGTH
anti-itch lotion for
Psoriasis
1% Hydrocortisone
net wt 3.4 oz (96 g)

CORTIZONE 10 FOR PSORIASIS
hydrocortizone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41167-0341
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	1 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PETROLATUM (UNII: 4T6H12BN9U)
DIMETHICONE (UNII: 92RU3N3Y1O)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
ISOHEXADECANE (UNII: 918X1OUF1E)
METHYL GLUCETH-20 (UNII: J3QD0LD11P)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SHEA BUTTER (UNII: K49155WL9Y)
OAT (UNII: Z6J799EAJK)
GINGER (UNII: C5529G5JPQ)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
BISABOLOL OXIDE B, (-)- (UNII: S32G48306Y)
CERAMIDE 3 (UNII: 4370DF050B)
CERAMIDE 2 (UNII: C04977SRJ5)
CERAMIDE EOS (UNII: CR0J8RN66K)
CERAMIDE 1 (UNII: 5THT33P7X7)
CERAMIDE 6 II (UNII: F1X8L2B00J)
N-HEXANOYLSPHINGOSINE (UNII: 038753E78J)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
CETEARETH-25 (UNII: 8FA93U5T67)
CHOLESTEROL (UNII: 97C5T2UQ7J)
BEHENIC ACID (UNII: H390488X0A)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
METHYLPARABEN (UNII: A2I8C7HI9T)
4-TERT-BUTYLCYCLOHEXANOL (UNII: K0H1405S9C)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41167-0341-0	96 g in 1 TUBE; Type 0: Not a Combination Product	01/15/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	01/15/2016

Labeler - Chattem, Inc. (003336013)

Cortizone 10 for Psoriasis