HYDROCORTISONE- hydrocortisone ointment 
Proficient Rx LP

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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
o
eczema
o
insect bites
o
poison ivy, poison oak, or poison sumac
o
soaps
o
detergents
o
cosmetics
o
jewelry
o
seborrheic dermatitis
o
psoriasis
o
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)

63187-543-01
HYDROCORTISONE 
hydrocortisone ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-543(NDC:51672-2018)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Hydrocortisone (UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ) Hydrocortisone1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Medium-chain triglycerides (UNII: C9H2L21V7U)  
Methylparaben (UNII: A2I8C7HI9T)  
Propylparaben (UNII: Z8IX2SC1OH)  
Petrolatum (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63187-543-011 in 1 CARTON12/01/2018
128.4 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01710/03/1989
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIBusiness Operations
Proficient Rx LP079196022REPACK(63187-543) , RELABEL(63187-543)

Revised: 2/2024
Document Id: da956cb1-6755-4155-a49c-3173cb7423cf
Set id: c57d5f8e-5934-4cbb-999a-cdd55e5b105f
Version: 4
Effective Time: 20240201
 
Proficient Rx LP