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HYDROCORTISONE MAXIMUM STRENGTH

Medically reviewed on February 23, 2018

Dosage form: cream
Ingredients: HYDROCORTISONE 10mg in 1g
Labeler: Aru Pharma Inc.
NDC Code: 70403-923

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.

QPACK HYDROCORTISONE CREAM 1%

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. 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.

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

HYDROCORTISONE MAXIMUM STRENGTH 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70403-923
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CETOSTEARYL ALCOHOL 
CETETH-20 
PARAFFIN 
MICROCRYSTALLINE WAX 
PROPYLENE GLYCOL 
LIGHT MINERAL OIL 
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM 
PROPYLPARABEN 
METHYLPARABEN 
CHLOROCRESOL 
WATER 
Product Characteristics
Colorwhite (white to off white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:70403-923-301 TUBE in 1 CARTON
130 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/01/2018
Labeler - Aru Pharma Inc. (079736192)

 
Aru Pharma Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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