Hydrocortisone Ointment Maximum Strength - Select Brand

Drug Labeling and Warnings

Drug Details [pdf]

HYDROCORTISONE MAXIMUM STRENGTH- hydrocortisone ointment 
L&R Distributors, Inc.

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 - Select Brand

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

SATISFACTION GUARANTEED

NDC: 15127-128-01
MAXIMUM STRENGTH
select brand®

Hydrocortisone Ointment, USP 1%
Anti-Itch Ointment
Relieves Itches and Helps Heal Rashes
Compare to the active ingredient of Cortizone10®*
NET WT 1 OZ (28g)

Hydrocortisone Ointment, USP 1%
HYDROCORTISONE  MAXIMUM STRENGTH
hydrocortisone ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 15127-128
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: 15127-128-011 in 1 CARTON05/13/200810/31/2018
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 FINALpart34805/13/200810/31/2018
Labeler - L&R Distributors, Inc. (012578514)
Registrant - Teva Pharmaceuticals USA, Inc. (001627975)

Revised: 7/2019
Document Id: ea5ec7dc-b672-4aec-9015-a8dabfc5eb3e
Set id: 9805a015-13d7-45f4-9d78-6d79eb3d0c52
Version: 6
Effective Time: 20190716