CORTIZONE 10 COOLING- hydrocortisone gel 
Chattem, Inc.

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Cortizone 10 Cooling Gel

Cortizone 10
Cooling Gel

Drug Facts

Active ingredient

Hydrocortisone 1%

Purpose

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

alcohol denat. (15%), aloe barbadensis leaf juice, avena sativa (oat) kernel extract, dextrin, dimethicone, disodium EDTA, glycerin, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, isohexadecane, maltodextrin, menthyl lactate, methyl gluceth-20, methylparaben, polysorbate 60, PPG-3 benzyl ether myristate, propylparaben, sodium citrate, water

PRINCIPAL DISPLAY PANEL

MAXIMUM STRENGTH
Cortizone 10

COOLING GEL
1% Hydrocortisone

Anti-Itch Creme
Net wt 1 oz (28 g)

MAXIMUM STRENGTH
Cortizone 10
COOLING GEL
1% Hydrocortisone 
Anti-Itch Crème
Net wt 1 oz (28 g)

CORTIZONE 10 COOLING 
hydrocortisone gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0033
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
ALCOHOL (UNII: 3K9958V90M)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
OAT (UNII: Z6J799EAJK)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PPG-3 BENZYL ETHER MYRISTATE (UNII: 8075L58MKO)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41167-0033-21 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: 10/2023
Document Id: 0640e34f-a935-4bab-a4ea-f8cfbe669289
Set id: 14d9fce2-9f54-4204-83cb-161de8a303f0
Version: 3
Effective Time: 20231025
 
Chattem, Inc.