CORTIZONE 10 INTENSIVE HEALING FEMININE ITCH RELIEF- hydrocortisone cream

Cortizone 10 Intensive Healing Feminine Itch Relief by

Drug Labeling and Warnings

Cortizone 10 Intensive Healing Feminine Itch Relief by is a Otc medication manufactured, distributed, or labeled by Chattem, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Maximum Strength Cotizone 10®  Feminine Relief Anti-Itch Creme

Drug Facts

Active ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

• temporarily relieves external feminine itching
  
• other uses of this product should only be under the advice and supervision of a doctor

Warnings

For external use only

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

• when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly then gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product 
  
• adults and children 12 years of age and older: apply a fingertip amount (approximately 1-inch strip) to affected area not more than 3 to 4 times daily
  
• children under 12 years of age: ask a doctor

Inactive ingredients

water, glycerin, dimethicone, petrolatum, jojoba esters, cetyl alcohol, aloe barbadensis leaf juice, stearyl alcohol, distearyldimonium chloride, cetearyl alcohol, steareth-21, steareth-2, chomomilla recutita (matricaria) flower extract, tocopheryl acetate, magnesium ascorbyl phosphate, retinyl palmitate, hydrolyzed collagen, hydrolyzed elastin, hydrolyzed jojoba esters, beta-glucan, glyceryl stearate, menthyl lactate, polysorbate 60, methyl gluceth-20, stearamidopropyl PG-dimonium chloride phosphate, PPG-12/SMDI copolymer, potassium hydroxide, diazolidinyl urea, propylene glycol, benzyl alcohol, methylparaben, BHT, propylparaben, EDTA (309-011) 

Principal Display Panel

Maximum Strength
Cotizone 10® 
Feminine Relief
Anti-Itch Creme
1% Hydrocortisone
Net wt 2 OZ (56 g)

INGREDIENTS AND APPEARANCE

CORTIZONE 10 INTENSIVE HEALING FEMININE ITCH RELIEF 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0335
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)
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)
CETYL ALCOHOL (UNII: 936JST6JCN)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
STEARETH-21 (UNII: 53J3F32P58)
STEARETH-2 (UNII: V56DFE46J5)
CHAMOMILE (UNII: FGL3685T2X)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
HYDROLYZED BOVINE ELASTIN (BASE; 1000 MW) (UNII: ZR28QKN0WT)
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)
POLYSORBATE 60 (UNII: CAL22UVI4M)
METHYL GLUCETH-20 (UNII: J3QD0LD11P)
STEARAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: W6000VEI5Y)
PPG-12/SMDI COPOLYMER (UNII: 1BK9DDD24E)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
BENZYL ALCOHOL (UNII: LKG8494WBH)
METHYLPARABEN (UNII: A2I8C7HI9T)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
EDETIC ACID (UNII: 9G34HU7RV0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0335-0	1 in 1 CARTON	01/01/2014
1		28 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 41167-0335-2	1 in 1 CARTON	01/01/2014
2		56 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 41167-0335-1	1 in 1 CARTON	01/01/2014
3		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	01/01/2014

Labeler - Chattem, Inc. (003336013)