HYDROCORTISONE- hydrocortisone cream 
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.

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Best Choice Hydrocortisone

Active Ingredient

Hydrocortisone 1.0%

Purpose

Anti-itch

Uses

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

Other uses of this product: ask a doctor

Warnings

For external use only

Do not use

  • in or near the eyes
  • by putting directly into the rectum by using fingers or any mechanical device or applicator
  • for external feminine itching if you have a vaginal discharge
  • for diaper rash: ask a doctor.

Ask a doctor or pharmacist before use if you are

using any other hydrocortisone product

When using this product

for external anal itching, do not exceed recommended daily dosage unless directed by a doctor

Stop use and ask a doctor if

  • condition worsens or does not improve within 7 days
  • symptoms clear up and return within a few days
  • rectal bleeding occurs

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

store at room temperature, protect from freezing

Inactive ingredients

aloe vera, butylated hydroxytoulene, carbomer 940, cetyl alcohol, ethylparaben, glycerin, glyceryl stearate, propylene glycol, purified water, sodium lauryl sulfate, stearic acid, trolamine

Package label

Best Choice Hydrocortisone Anti-Itch Cream

image of carton

HYDROCORTISONE 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63941-312
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
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SQUALENE (UNII: 7QWM220FJH)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63941-312-011 in 1 BOX02/29/2012
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 finalpart34802/29/2012
Labeler - Valu Merchandisers, Co. (868703513)

Revised: 1/2023
Document Id: f3449a7c-6813-4cd1-e053-2995a90a05c8
Set id: ef50b207-236f-444a-9453-b6d90628ea84
Version: 5
Effective Time: 20230127
 
Valu Merchandisers, Co.