Children's Cotizone 10 Cooling Cream with Aloe

Cortizone 10 Cooling Cream Anti-Itch by

Drug Labeling and Warnings

Cortizone 10 Cooling Cream Anti-Itch by is a Otc medication manufactured, distributed, or labeled by Chattem, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CORTIZONE 10 COOLING CREAM ANTI-ITCH- hydrocortisone cream 
Chattem, Inc.

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.

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Children's Cotizone 10 Cooling Cream with Aloe

Active ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

• temporarily relieves itching and discomfort associated with 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

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 eyes
• do not use more than directed unless told to do so by a doctor

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

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: ask a doctor

Inactive ingredients

water, SD alcohol 40 (15%), glycerin, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, dextrin, isohexadecane, menthyl lactate, menthyl gluceth-20, PPG-3 benzyl ether myristate, phenoxyethanol, dimethicone, hydrolyzed jojoba esters, polysorbate 60, bisabolol, disodium EDTA, benzoic acid, dehydroacetic acid, jojoba esters, ethylhexylglycerin, sodium citrate, avena sativa (oat) kernel extract, aloe barbadensis leaf juice, maltodextrin, zingiber officinale (ginger) root extract (309-073) 

Principal Display Panel

Children's Cortizone-10 Cooling Cream
Net wt 1 OZ (28 g)
1% Hydrocortisone Anti-Itch
Cooling Cream

CORTIZONE 10 COOLING CREAM ANTI-ITCH 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0031
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)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
ICODEXTRIN (UNII: 2NX48Z0A9G)
ISOHEXADECANE (UNII: 918X1OUF1E)
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)
PPG-3 BENZYL ETHER MYRISTATE (UNII: 8075L58MKO)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DIMETHICONE (UNII: 92RU3N3Y1O)
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
LEVOMENOL (UNII: 24WE03BX2T)
EDETATE DISODIUM (UNII: 7FLD91C86K)
BENZOIC ACID (UNII: 8SKN0B0MIM)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
OAT (UNII: Z6J799EAJK)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
GINGER (UNII: C5529G5JPQ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0031-6	1 in 1 CARTON	12/02/2013	02/28/2019
1		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 NOT FINAL	part348	12/02/2013	02/28/2019

Labeler - Chattem, Inc. (003336013)

Revised: 12/2019

Document Id: 550ed707-dc66-4bd6-8c04-f4247348f307

34390-5

Set id: ba390943-2784-4ac7-9489-133fb7dc4b5f

Version: 2

Effective Time: 20191216

 

Chattem, Inc.