Label: CORTIZONE 10 ITCH RELIEF MASSAGING ROLLERBALL- hydrocortisone cream
- NDC Code(s): 41167-0338-0
- Packager: Chattem, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated May 1, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
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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
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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
- Directions
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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
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INGREDIENTS AND APPEARANCE
CORTIZONE 10 ITCH RELIEF MASSAGING ROLLERBALL
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-0338 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) 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:41167-0338-0 1 in 1 CARTON 01/02/2023 1 42 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 01/02/2023 Labeler - Chattem, Inc. (003336013)