HYDROCORTISONE- hydrocortisone ointment 
Valu Merchandisers, Co.

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.

----------

Best Choice Hydrocortisone Ointment

Active Ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

temporarily relieves itching associated with minor skin irritation, inflammation and rashes due to:

eczema

psoriasis

poison ivy, oak, sumac

insect bites

detergents

jewelry

cosmetics

soaps

seborrheic dermatitis

temporarily relieves external anal and genital itching



other uses of this product should only be under the advice and supervision of a doctor


other uses of this product should only be under the advice and supervision of a doctor

Warnings

For external use only

Do not use

  • in the genital area 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 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 right away.

Directions

for itching of skin irritation, inflammation, and rashes:

for external anal and genital itching, adults:

Other information

store at room temperature

Inactive ingredient

petrolatum

Package label

Best Choice Hydrocortisone carton

HYDROCORTISONE 
hydrocortisone ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63941-313
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63941-313-011 in 1 BOX01/30/2012
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 finalpart34801/30/2012
Labeler - Valu Merchandisers, Co. (868703513)

Revised: 2/2023
Document Id: f43630ef-eb3d-076f-e053-2995a90a79ed
Set id: 2871aafd-1be7-4ec9-a364-62bcaf97b416
Version: 5
Effective Time: 20230208
 
Valu Merchandisers, Co.