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 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, dimethicone, petrolatum, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, cetyl alcohol, dextrin, glyceryl stearate, ishexadecane, methyl gluceth-20, aloe barbadensis leaf extract, avena sativa (oat) kernel extract, chamomilla recutita (matricaria) flower extract, butyrospermum parkii (shae) butter extract, boswellia serrata gum, zingiber officinale (ginger) root extract, bisabolol, magnesium ascorbyl phosphate, tocopheryl acetate, malodextrin, ethylhexylglycerin, dehydroacetic acid, polysorbate 60, phenoxyethanol, disodium EDTA, dipropylene glycol, benzoic acid, pentylene glycol, 4-t-butylcyclohexanol, sodium citrate

Principal Display Panel

Cortizone 10®
MAXIMUM STRENGTH
anti-itch lotion for
Diabetics' Skin
fast, lasting relief
to soothe dry, irritated skin
1% Hydrocortisone
Net wt 3.4 oz (96 g)

CORTIZONE 10 ANTI-ITCH FOR DIABETICS SKIN
hydrocortisone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41167-0342
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)
DIMETHICONE (UNII: 92RU3N3Y1O)
PETROLATUM (UNII: 4T6H12BN9U)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
CETYL ALCOHOL (UNII: 936JST6JCN)
ICODEXTRIN (UNII: 2NX48Z0A9G)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISOHEXADECANE (UNII: 918X1OUF1E)
METHYL GLUCETH-20 (UNII: J3QD0LD11P)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
OAT (UNII: Z6J799EAJK)
CHAMOMILE (UNII: FGL3685T2X)
SHEANUT OIL (UNII: O88E196QRF)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
GINGER (UNII: C5529G5JPQ)
LEVOMENOL (UNII: 24WE03BX2T)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
BENZOIC ACID (UNII: 8SKN0B0MIM)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
4-TERT-BUTYLCYCLOHEXANOL (UNII: K0H1405S9C)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:41167-0342-0	1 in 1 CARTON	12/22/2014
1		96 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	12/22/2014

Labeler - Chattem, Inc. (003336013)

Cortizone 10 Anti-itch Lotion for Diabetics Skin