HYDROCORTISONE MAXIMUM STRENGTH- hydrocortisone cream

HYDROCORTISONE MAXIMUM STRENGTH by

Drug Labeling and Warnings

HYDROCORTISONE MAXIMUM STRENGTH by is a Otc medication manufactured, distributed, or labeled by Aru Pharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Hydrocortisone USP 1%

Purpose

Anti-itch

Uses

for temporary relief of itching associated with minor skin irritations and rashes due to: Eczema Insect bites Soaps and detergents  Cosmetics Jewelry Seborrheic dermatitis Psoriasis Poison ivy, oak or sumac For external genital, feminine 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  In children under 2 years of age If you have a vaginal discharge For the treatment of diaper rash

Ask a doctor before use if you have External genital or feminine itching External anal itching Bleeding

When using this product  Avoid contact with eyes  Do not exceed the recommended daily dosage unless directed 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, or if symptoms persist for more than 7 days or clear up and occur again within a few days, stop use and do not begin use of any other hydrocortisone product, unless you have consulted a doctor.

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. (1-800-222-1222)

Directions

For minor skin irritations and rashes, adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily. For external anal itching:  Adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly  Gently dry by patting or blotting with toilet tissue or soft cloth before application of this product Children: under 12 years of age, consult a doctor.

Inactive ingredients

Cetostearyl Alcohol, Cetomacrogol 1000, Paraffin Wax, Micro Crystalline Wax, Propylene Glycol, Light Liquid Paraffin, Mono basic Sodium Phosphate, Propyl Paraben, Methyl Paraben, Chlorocresol, Purified Water

Other information

Do not use if seal is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal

store at room temperature See crimp of tube or carton for Lot Number and Expiration Date

Questions or comments?

1 844 500-2729‬ between 9 am and 4 pm EST, Monday to Friday.

SPL UNCLASSIFIED SECTION

MAXIMUM STRENGTH ANTI-ITCH CREAM

Temporary Relief the Discomfort of itching, Rashes and Irritation on Skin Due to Eczema, Psoriasis and Insect bites

Compared to the active ingredient in Cortizone 10

Distributed by.

ARU PHARMA INC.

MOUNT VERNON, NY 10552

www.qpackrx.com

Packaging

INGREDIENTS AND APPEARANCE

HYDROCORTISONE MAXIMUM STRENGTH 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70403-923
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
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETETH-20 (UNII: I835H2IHHX)
PARAFFIN (UNII: I9O0E3H2ZE)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
METHYLPARABEN (UNII: A2I8C7HI9T)
CHLOROCRESOL (UNII: 36W53O7109)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white (white to off white)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70403-923-30	1 in 1 CARTON	01/01/2018
1		30 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	01/01/2018

Labeler - Aru Pharma Inc. (079736192)