MAXIMUM STRENGTH HYDROCORTISONE ANTI-ITCH- hydrocortisone 1% cream

Maximum Strength Hydrocortisone Anti-itch by

Drug Labeling and Warnings

Maximum Strength Hydrocortisone Anti-itch by is a Otc medication manufactured, distributed, or labeled by Target Corporation, Sheffield Pharmaceuticals LLC, Sheffield Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts 

Active Ingredient

Hydrocortisone 1.0%

Purpose

Anti-itch

Uses

For temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:

• eczema
• insect bites
• poison ivy
• poison oak
• poison sumac
• soaps
• detergents
• cosmetics
• jewelry
• seborrheic dermatitis
• psoriasis
• external feminine, genital and anal itching.
• 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.
• for external genital itching if you have a vaginal discharge, consult a doctor.

When using this product 

• avoid contact with eyes
• do not use more than directed unless told ot do so by a doctor
• do not put this product 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, discontinue use of this product and do not begin use of any other hydrocortisone product unless directed by a doctor.
• rectal bleeding occurs 

KEEP OUT OF REACH OF CHILDREN

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

Other information 

store at a controlled room temperature 20 - 25ºC (68 - 77ºF).

Inactive Ingredients:

 Aloe Barbadensis Leaf Juice, Aluminum Sulfate, Beeswax, Calcium Acetate, Cetearyl Alcohol, Dextrin, Glycerin, Maltodextrin, Methylparaben, Mineral Oil, Petrolatum, Propylparaben, Sodium Cetearyl Sulfate, Sodium Lauryl Sulfate, Purified Water

Questions & Comments ? 1-800-910-6874

Principal Display Panel 

Target Up&Up       NDC: 11673-890-56

Maxminium Strenght Hydrocortisone Cream 

Hydrocortisone 1%

Anti-itch 

NET WT 2OZ (56g)

TOTAL NET WT 4OZ (112g)

INGREDIENTS AND APPEARANCE

MAXIMUM STRENGTH HYDROCORTISONE ANTI-ITCH 
hydrocortisone 1% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11673-890
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALUMINUM SULFATE (UNII: 34S289N54E)
YELLOW WAX (UNII: 2ZA36H0S2V)
CALCIUM ACETATE (UNII: Y882YXF34X)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ICODEXTRIN (UNII: 2NX48Z0A9G)
GLYCERIN (UNII: PDC6A3C0OX)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11673-890-56	2 in 1 CARTON	01/31/2024
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	01/31/2024

Labeler - Target Corporation (006961700)

Registrant - Sheffield Pharmaceuticals LLC (151177797)

Establishment
Name	Address	ID/FEI	Business Operations
Sheffield Pharmaceuticals LLC		151177797	MANUFACTURE(11673-890) , analysis(11673-890)