CORTISONE 10 INTENSIVE MOISTURE CREME- hydrocortisone cream

Cortisone 10 Intensive Moisture Creme by

Drug Labeling and Warnings

Cortisone 10 Intensive Moisture 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 Intensive Moisture Creme

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  

water, glycerin, petrolatum, jojoba esters, cetyl alcohol, aloe barbadensis leaf juice, stearyl alcohol, distearyldimonium chloride, cetearyl alcohol, steareth-2, steareth-21, magnesium ascorbyl phosphate, chamomilla recutita (matricaria) flower extract, hydrolyzed jojoba esters, tocopheryl acetate, niacinamide, polysorbate 60, stearamidopropyl PG-dimonium chloride phosphate, dimethicone, glyceryl stearate, hydroxyacetophenone, methyl gluceth-20, menthyl lactate, propylene glycol, ethylhexylglycerin, PPG-12/SMDI copolymer, disodium EDTA, beta-glucan (357-178)

PRINCIPAL DISPLAY PANEL

MAXIMUM STRENGTH
Cortizone 10
INTENSIVE MOISTURE CREME
1% Hydrocortisone
Anti-Itch Creme
Net wt 1 oz (28 g)

INGREDIENTS AND APPEARANCE

CORTISONE 10 INTENSIVE MOISTURE CREME 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0022
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)
PETROLATUM (UNII: 4T6H12BN9U)
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)
CETYL ALCOHOL (UNII: 936JST6JCN)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
STEARETH-2 (UNII: V56DFE46J5)
STEARETH-21 (UNII: 53J3F32P58)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
CHAMOMILE (UNII: FGL3685T2X)
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
NIACINAMIDE (UNII: 25X51I8RD4)
POLYSORBATE 60 (UNII: CAL22UVI4M)
STEARAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: W6000VEI5Y)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
METHYL GLUCETH-20 (UNII: J3QD0LD11P)
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PPG-12/SMDI COPOLYMER (UNII: 1BK9DDD24E)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
TRANSFORMING GROWTH FACTOR BETA RECEPTOR TYPE 3 (UNII: 18YWT2KYS8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0022-0	1 in 1 CARTON	01/01/2023
1		28 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 41167-0022-5	1 in 1 CARTON	01/01/2023
2		56 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 41167-0022-6	2 in 1 CARTON	01/01/2023
3		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 Drug	M017	01/01/2023

Labeler - Chattem, Inc. (003336013)