CORTIZONE 10 ANTI-ITCH FOR DIABETICS SKIN- hydrocortisone lotion

Cortizone 10 Anti-itch for Diabetics Skin by

Drug Labeling and Warnings

Cortizone 10 Anti-itch for Diabetics Skin by is a Otc medication manufactured, distributed, or labeled by Chattem, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Cotizone 10® Maximum Strength Anti-Itch Lotion for Diabetics' Skin

Drug Facts

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)

INGREDIENTS AND APPEARANCE

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	12/22/2014

Labeler - Chattem, Inc. (003336013)