CORTIZONE 10 ITCH RELIEF MASSAGING ROLLERBALL- hydrocortisone cream 
Chattem, Inc.

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Cortizone 10 Itch Relief Massaging Rollerball

Cortizone 10 Itch Relief Massaging Rollerball

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

 other uses of this product should be only 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. 

■ if you are allergic to any ingredient in this product

When using this product

 avoid contact with the 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, do not use this or 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: do not use, ask a doctor

Inactive ingredients

water, alcohol denat. (15%), dimethicone, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, glycerin, ethylhexylglycerin, aloe barbadensis leaf juice, hydroxyacetophenone, glyceryl stearate, C30-45 alkyl cetearyl dimethicone crosspolymer, isohexadecane, acrylates/C10-30 alkyl acrylate crosspolymer, dicetyl phosphate, aminomethyl propanol, steareth-2, steareth-21, polysorbate 60, disodium EDTA, citric acid

PRINCIPAL DISPLAY PANEL

Cortizone 10
Itch Relief
Massaging Rollerball 1.5 FL OZ (44.3 mL)

PRINCIPAL DISPLAY PANEL
Cortizone 10 
Itch Relief 
Massaging Rollerball 1.5 FL OZ (44.3 mL)

CORTIZONE 10 ITCH RELIEF MASSAGING ROLLERBALL 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0338
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)  
ALCOHOL (UNII: 3K9958V90M)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETETH-20 PHOSPHATE (UNII: 921FTA1500)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
GLYCERIN (UNII: PDC6A3C0OX)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
C30-45 ALKYL CETEARYL DIMETHICONE CROSSPOLYMER (UNII: 4ZK9VP326R)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
STEARETH-2 (UNII: V56DFE46J5)  
STEARETH-21 (UNII: 53J3F32P58)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41167-0338-01 in 1 CARTON01/02/2023
142 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01701/02/2023
Labeler - Chattem, Inc. (003336013)

Revised: 11/2023
Document Id: 8048b1af-5b6a-4582-9fb0-07fee1f83fd0
Set id: 1e27682c-f856-41f1-9935-37540960a4c7
Version: 2
Effective Time: 20231106
 
Chattem, Inc.