CORTIZONE 10 SENSITIVE SKIN ANTI-ITCH CREME- hydrocortisone cream

Cortizone 10 Sensitive Skin Anti-itch Creme by

Drug Labeling and Warnings

Cortizone 10 Sensitive Skin Anti-itch 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

Sensitive Skin Anti-itch Creme

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.

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, or 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

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, 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

PRINCIPAL DISPLAY PANEL

Sensitive Skin
Itch Relief
2 oz Size

INGREDIENTS AND APPEARANCE

CORTIZONE 10 SENSITIVE SKIN ANTI-ITCH CREME 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0336
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 (45000 MPA.S AT 1%) (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)
ICODEXTRIN (UNII: 2NX48Z0A9G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0336-0	1 in 1 CARTON	01/01/2022
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 Drug	M017	01/01/2022

Labeler - Chattem, Inc. (003336013)