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Hydrocortisone by Proficient Rx LP

Medically reviewed on February 1, 2018

Dosage form: ointment
Ingredients: Hydrocortisone 1g in 100g
Labeler: Proficient Rx LP
NDC Code: 63187-543

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

Drug Facts

Active ingredient

Hydrocortisone 1%

Purpose

Anti-itch ointment

Uses
temporary relief of itching associated with minor skin irritations and rashes due to
eczema
insect bites
poison ivy, poison oak, or poison sumac
soaps
detergents
cosmetics
jewelry
seborrheic dermatitis
psoriasis
external 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
in the eyes
by putting this product into the rectum by using fingers or any mechanical device or applicator

Ask a doctor before use if you have
a vaginal discharge
rectal bleeding
diaper rash

When using this product consult a doctor before exceeding recommended dosage

Stop use and ask a doctor if
condition gets worse
condition persists for more than 7 days
condition clears up and occurs again within a few days. Do not begin to use 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.

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
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

Other information
To open: unscrew cap, pull tab to remove foil seal, and screw cap back onto tube
store at room temperature
see carton or tube crimp for lot number and expiration date

Inactive ingredients

Fractionated Coconut Oil, Methylparaben, Propylparaben, White Petrolatum

Questions?

Call 1-866-923-4914

Distributed by:
Taro Pharmaceuticals
U.S.A., Inc.
Hawthorne, NY 10532

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

Itch and Rash Relief
MAXIMUM STRENGTH

Hydrocortisone 1%
Ointment

Antipruritic (Anti-Itch)
NET WT 1 oz (28.4 g)

HYDROCORTISONE 
hydrocortisone ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-543(NDC:51672-2018)
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Hydrocortisone (Hydrocortisone) Hydrocortisone1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Medium-chain triglycerides 
Methylparaben 
Propylparaben 
Petrolatum 
Packaging
#Item CodePackage Description
1NDC:63187-543-011 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 finalpart34810/03/1989
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIOperations
Proficient Rx LP079502574REPACK(63187-543), RELABEL(63187-543)

 
Proficient Rx LP

← See all Hydrocortisone brands

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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