HYDROCORTISONE MAXIMUM STRENGTH- hydrocortisone ointment 
Proficient Rx LP

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.

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Hydrocortisone Ointment Maximum Strength - Actavis

Drug Facts

Active ingredient

Hydrocortisone, USP 1%

Purpose

Anti-itch

Uses

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

eczema
insect bites
poison ivy
poison oak
poison sumac
soaps
jewelry
detergents
cosmetics
psoriasis
seborrheic dermatitis
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

for external feminine itching if you have a vaginal discharge. Consult a doctor.
for the treatment of diaper rash. Consult a doctor.

When using this product

 
avoid contact with the eyes
 
do not begin the use of any other hydrocortisone product unless directed by a doctor
 
for external anal itching:
 
do not use more than directed 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

symptoms last for more than 7 days
the condition gets worse
symptoms clear up and occur again in a few days
rectal bleeding occurs, consult doctor promptly

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, clean the affected area with mild soap and warm water, 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

Store at room temperature 59°-86°F (15°-30°C).
Before using any medication, read all label directions. Keep carton, it contains important information.

Inactive ingredients

mineral oil, white petrolatum

Questions?

1-800-432-8534 between 9 am and 4 pm EST, Monday–Friday.

PRINCIPAL DISPLAY PANEL

Distributed by:

Actavis Pharma Inc.

Parsippany, NJ 07054

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

Proficient Rx
NDC 71205-034-30
Compare to the active ingredient in Cortizone•10®*

Maximum Strength
Hydrocortisone Ointment, USP 1%
Anti-Itch Ointment

Relieves Itches and Rashes
Net wt. 1 oz (28g)

For the temporary relief of itches and rashes due to:
• Insect Bites     • Eczema     • Seborrheic dermatitis
• Poison Ivy, oak & sumac

71205-034-30
HYDROCORTISONE  MAXIMUM STRENGTH
hydrocortisone ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71205-034(NDC:0472-0345)
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
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71205-034-301 in 1 CARTON05/01/2018
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/21/1998
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIBusiness Operations
Proficient Rx LP079196022RELABEL(71205-034)

Revised: 1/2021
Document Id: b27ef9e6-7c67-4af6-aeef-427cbbe017e2
Set id: b7ff20ee-b092-4831-bfe7-517d4c2558e8
Version: 4
Effective Time: 20210101
 
Proficient Rx LP