Label: CORTISONE 10 SENSITIVE SKIN CREME- hydrocortisone cream
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- NDC Code(s): 41167-0028-0
- Packager: Chattem, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 5, 2023
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- 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 only be under the advice and supervision of a doctor
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Warnings
For external use only
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, glycerin, dimethicone, petrolatum, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, cetyl alcohol, dextrin, glyceryl stearate, isohexadecane, methyl gluceth-20, avena sativa (oat) kernel extract, tocopheryl acetate, magnesium ascorbyl phosphate, aloe barbadensis leaf juice, chamomilla recutita (matricaria) flower extract, butyrospermum parkii (shea) butter extract, zingiber officinale (ginger) root extract, boswellia serrata gum, bisabolol, maltodextrin, ethylhexylglycerin, pentylene glycol, phenoxyethanol, disodium EDTA, dipropylene glycol, 4-t-butylcyclohexanol, benzoic acid, polysorbate 60, sodium citrate, citric acid
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INGREDIENTS AND APPEARANCE
CORTISONE 10 SENSITIVE SKIN CREME
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-0028 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) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4) CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) ISOHEXADECANE (UNII: 918X1OUF1E) METHYL GLUCETH-20 (UNII: J3QD0LD11P) OAT (UNII: Z6J799EAJK) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5) ALOE VERA LEAF (UNII: ZY81Z83H0X) CHAMOMILE (UNII: FGL3685T2X) SHEA BUTTER (UNII: K49155WL9Y) GINGER (UNII: C5529G5JPQ) INDIAN FRANKINCENSE (UNII: 4PW41QCO2M) LEVOMENOL (UNII: 24WE03BX2T) MALTODEXTRIN (UNII: 7CVR7L4A2D) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) PENTYLENE GLYCOL (UNII: 50C1307PZG) PHENOXYETHANOL (UNII: HIE492ZZ3T) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) DIPROPYLENE GLYCOL (UNII: E107L85C40) 4-TERT-BUTYLCYCLOHEXANOL (UNII: K0H1405S9C) BENZOIC ACID (UNII: 8SKN0B0MIM) POLYSORBATE 60 (UNII: CAL22UVI4M) SODIUM CITRATE (UNII: 1Q73Q2JULR) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41167-0028-0 1 in 1 CARTON 01/01/2023 1 56 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 01/01/2023 Labeler - Chattem, Inc. (003336013)
