HYDROCORTISONE ANTI-ITCH- hydrocortisone cream

Hydrocortisone Anti-Itch by

Drug Labeling and Warnings

Hydrocortisone Anti-Itch by is a Otc medication manufactured, distributed, or labeled by Universal Distribution Center LLC, Anicare Pharmaceuticals Pvt. Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Hydrocortisone 1%

PURPOSE

Purpose

Anti-itch

INDICATIONS & USAGE

Uses

for the temporary relief of itching associated with minor skin irritations and rashes due to:

• eczema
• seborrheic dermatitis
• psoriasis
• insect bites
• poison ivy, oak, sumac
• soaps
• detergents
• cosmetics
• jewelry
• external genital, feminine and anal itching

Other uses or the use of the product for more than 7 days should be undertaken only under the advice and supervision of a doctor

WARNINGS

Warnings

• For external use only
• Avoid contact with eyes

STOP USE

Stop using this product and ask a doctor

• if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
• before you begin  to using any other hydrocortisone product

DO NOT USE

Do not use this product and ask a doctor

• if you have a vaginal discharge
• before treating diaper rash
• before using on children under 2 years of age

SPL UNCLASSIFIED SECTION

For external anal itching users

• do not exceed the recommended daily dosage unless directed by a doctor
• in case of bleeding, consult a doctor promptly
• do not put this product into rectum by using fingers or any mechanical device or applicator
• before using on children under 2 years of age

KEEP OUT OF REACH OF CHILDREN

Keep this and all drugs out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. Before using any medication, read all label directions. Keep this carton. It contains important information.

DOSAGE & ADMINISTRATION

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, consult a doctor

For external anal  itching users:

• Adult: when practical, cleanse the affected area with mild soap and water and rinse thoroughly
• gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
• Children under 12 years of age: consult a doctor

SPL UNCLASSIFIED SECTION

Other information

• Store at room temperature
• Lot No. & Exp. Date: see box or see crimp of tube

INACTIVE INGREDIENT

Inactive Ingredients

Purified Water, Mineral Oil, Propylene Glycol, Cetearyl Alcohol, Petrolatum, Glyceryl Stearate, Polysorbate 60, Sorbitan Stearate, Methylparaben, Propylparaben, Disodium Edta

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

HYDROCORTISONE ANTI-ITCH CREAM

NET WT 0.5 OZ. (14 g)

INGREDIENTS AND APPEARANCE

HYDROCORTISONE ANTI-ITCH 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52000-022
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	0.01 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MINERAL OIL (UNII: T5L8T28FGP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PETROLATUM (UNII: 4T6H12BN9U)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
POLYSORBATE 60 (UNII: CAL22UVI4M)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
EDETATE SODIUM (UNII: MP1J8420LU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52000-022-37	1 in 1 BOX
1	NDC: 52000-022-36	14 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	04/15/2015

Labeler - Universal Distribution Center LLC (019180459)

Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)

Establishment
Name	Address	ID/FEI	Business Operations
Anicare Pharmaceuticals Pvt. Ltd		916837425	manufacture(52000-022)