CORTISONE 10 OVERNIGHT CREME- hydrocortisone cream 
Chattem, Inc.

----------

Cortizone 10 Overnight Creme

Cortizone 10 Overnight Relief

Drug Facts

Active ingredient

Purpose

Hydrocortisone 1%...........................................................................................................................................Anti-itch

Uses  

temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:  

      ■ eczema ■ psoriasis  ■ poison ivy, oak, sumac  ■ insect bites ■ detergents ■ jewelry ■ cosmetics

      ■ soaps ■ seborrheic dermatitis

 temporarily relieves external anal and genital itching

 other uses of this product should only be under the advice and supervision of a doctor

Warnings

For external use only

Do not use

■ in the genital area if you have a vaginal discharge. Consult a doctor.

■ 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

 do not put directly into the rectum by using fingers or any mechanical device or applicator

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

■ rectal bleeding occurs

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

■ for itching of skin irritation, inflammation, and rashes:  

      ■ 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

 for external anal and genital itching, adults:

      ■ when practical, clean the affected area with mild soap and warm water and rinse thoroughly

      ■ gently dry by patting or blotting with toilet tissue or a soft cloth before applying

      ■ apply 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-2, steareth-21, beta-glucan, melatonin, methyl gluceth-20, hydroxyacetophenone, ethylhexylglycerin, chamomilla recutita (matricaria) flower extract, tocopheryl acetate, magnesium ascorbyl phosphate, hydrolyzed jojoba esters, propylene glycol, polysorbate 60, stearamidopropyl PG-dimonium chloride phosphate, glyceryl stearate, menthyl lactate, EDTA, PPG-12/SMDI copolymer, potassium hydroxide, methylparaben, fragrance

PRINCIPAL DISPLAY PANEL

Cortizone 10
Overnight Crème
Net
wt 1 oz (28 g)

PRINCIPAL DISPLAY PANEL
Cortizone 10
Overnight Crème
Net wt 1 oz (28 g)

CORTISONE 10 OVERNIGHT CREME 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0109
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PETROLATUM (UNII: 4T6H12BN9U)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
STEARETH-2 (UNII: V56DFE46J5)  
STEARETH-21 (UNII: 53J3F32P58)  
MELATONIN (UNII: JL5DK93RCL)  
METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
CHAMOMILE (UNII: FGL3685T2X)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
STEARAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: W6000VEI5Y)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
EDETIC ACID (UNII: 9G34HU7RV0)  
PPG-12/SMDI COPOLYMER (UNII: 1BK9DDD24E)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
TRANSFORMING GROWTH FACTOR BETA RECEPTOR TYPE 3 (UNII: 18YWT2KYS8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41167-0109-21 in 1 CARTON01/01/2023
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01701/01/2023
Labeler - Chattem, Inc. (003336013)

Revised: 11/2023
Document Id: 008eb825-61d4-4d90-9815-53a396b79c76
Set id: ef2eda7e-d6a8-47e3-9d80-6074af6773dc
Version: 2
Effective Time: 20231106
 
Chattem, Inc.