CORTAID 12-HOUR ADVANCED ANTI-ITCH- hydrocortisone cream

Cortaid 12-Hour Advanced by

Drug Labeling and Warnings

Cortaid 12-Hour Advanced by is a Otc medication manufactured, distributed, or labeled by Bausch Health US, LLC, Product Quest Mfg, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

• temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
• eczema
• insect bites
• poison ivy, oak, or sumac
• soaps
• detergents
• cosmetics
• jewelry
• seborrheic dermatitis
• psoriasis
• 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.

When using this product

avoid contact with eyes

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

Other information

• store at 20° to 25°C (68 to 77°F)

Inactive ingredients

aloe barbadensis leaf juice, benzyl alcohol, ceteareth-20, cetearyl alcohol, cetyl palmitate, citric acid, cyclopentasiloxane, dimethicone/vinyltrimethylsiloxysilicate crosspolymer, dimethyl MEA, feverfew extract, glycerin, isopropyl myristate, isostearyl neopentanoate, methylparaben, oat kernel extract, PEG-40 stearate, potassium lactate, *sodium hydroxide, water *may contain this ingredient

Questions/comments:

1-800-321-4576

Package/Label Principal Display Panel

DOCTOR

RECOMMENDED BRAND

CORTAID®

HYDROCORTISONE ANTI-ITCH CREAM

Lasts

longer than

Cortizone-10®*

12-HOUR

ADVANCED

ANTI-ITCH CREAM

With

ITCH-SHIELD™ technology.

Seals maximum strength

medicine for 12 hours

NET WT

1.5OZ (42 g)

INGREDIENTS AND APPEARANCE

CORTAID 12-HOUR ADVANCED  ANTI-ITCH
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0187-5519
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BENZYL ALCOHOL (UNII: LKG8494WBH)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DEANOL (UNII: 2N6K9DRA24)
TANACETUM PARTHENIUM (UNII: 6GE7Z0761K)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
METHYLPARABEN (UNII: A2I8C7HI9T)
OAT (UNII: Z6J799EAJK)
PEG-40 STEARATE (UNII: ECU18C66Q7)
POTASSIUM LACTATE (UNII: 87V1KMK4QV)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0187-5519-15	1 in 1 CARTON	10/01/2012
1		42 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	10/01/2012

Labeler - Bausch Health US, LLC (831922488)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg, LLC		927768135	MANUFACTURE(0187-5519)