CORTIZONE 10 ULTRA SOOTHING CREME- hydrocortisone cream

Cortizone 10 Ultra Soothing Creme by

Drug Labeling and Warnings

Cortizone 10 Ultra Soothing Creme by is a Otc medication manufactured, distributed, or labeled by Chattem, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Cortizone 10 Ultra Soothing Creme

Drug Facts

Active ingredient

Hydrocortisone1%

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

water, cetearyl alcohol, glycerin, petrolatum, mineral oil, isopropyl palmitate, sodium lauryl sulfate, beeswax, sodium cetearyl sulfate, methylparaben, tocopheryl acetate, propylparaben, propylene glycol, cetyl alcohol, aluminum sulfate, calcium acetate, dextrin, zea mays (corn) oil, cholecalciferol, retinyl palmitate, aloe barbadensis leaf Juice, maltodextrin (309-071)

Principal Display Panel

Cortizone 10
ULTRA SOOTHING CREME
1% Hydrocortisone
Anti-itch Creme
Net wt 1 oz (28 g)

INGREDIENTS AND APPEARANCE

CORTIZONE 10 ULTRA SOOTHING CREME 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0027
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)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERIN (UNII: PDC6A3C0OX)
PETROLATUM (UNII: 4T6H12BN9U)
MINERAL OIL (UNII: T5L8T28FGP)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
YELLOW WAX (UNII: 2ZA36H0S2V)
SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)
METHYLPARABEN (UNII: A2I8C7HI9T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CETYL ALCOHOL (UNII: 936JST6JCN)
ALUMINUM SULFATE (UNII: 34S289N54E)
CALCIUM ACETATE (UNII: Y882YXF34X)
CORN OIL (UNII: 8470G57WFM)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MALTODEXTRIN (UNII: 7CVR7L4A2D)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0027-5	1 in 1 CARTON	01/01/2023
1		56 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 41167-0027-0	1 in 1 CARTON	01/01/2023
2		28 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 Drug	M017	01/01/2023

Labeler - Chattem, Inc. (003336013)