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Hydrocortisone by Proficient Rx LP

Medically reviewed on Feb 1, 2018

Dosage form: cream
Ingredients: HYDROCORTISONE 10mg in 1g
Labeler: Proficient Rx LP
NDC Code: 63187-303

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.

Hydrocortisone Maximum Strength

Active ingredient

Hydrocortisone 1.0%

Purpose

Anti-itch

Uses

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

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

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 vaginal discharge. Consult a doctor.

When using this product
avoid contact with eyes   
do not use more than directed unless told to do so by a doctor  
do not put directly 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, and do not begin use of any other hydrocortisone product unless you have asked a doctor  
rectal bleeding occurs

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

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

adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with toilet tissue or a soft cloth before application of this product
children under 12 years of age with external anal itching: consult a doctor

Other information
store at 15° to 30°C (59° to 86°F)
lot number and expiration date: See crimp of tube or box

You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.

Inactive ingredients

cetyl alcohol, diazolidinyl urea, isopropyl palmitate, mineral oil/lanolin alcohol, polysorbate 40, propylene glycol, propylene glycol monostearate, purified water, sorbic acid, sorbitan monopalmitate, stearyl alcohol, xanthan gum

PRINCIPAL DISPLAY PANEL
HYDROCORTISONE 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-303(NDC:0603-0535)
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CETYL ALCOHOL 
DIAZOLIDINYL UREA 
ISOPROPYL PALMITATE 
MINERAL OIL 
LANOLIN ALCOHOLS 
POLYSORBATE 40 
PROPYLENE GLYCOL 
PROPYLENE GLYCOL STEARATE 
WATER 
SORBIC ACID 
SORBITAN MONOPALMITATE 
STEARYL ALCOHOL 
XANTHAN GUM 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:63187-303-011 TUBE in 1 CARTON
128.4 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/01/2001
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIOperations
Proficient Rx LP079196022REPACK(63187-303), RELABEL(63187-303)

 
Proficient Rx LP

← See all Hydrocortisone brands

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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