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Hydrocortisone by Valu Merchandisers, Co.

Dosage form: cream
Ingredients: HYDROCORTISONE 10mg in 1g
Labeler: Valu Merchandisers, Co.
NDC Code: 63941-312

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.

Drug Facts

Active Ingredient

Hydrocortisone 1.0%

Purpose

Anti-itch

Uses

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

  • eczema
  • psoriasis
  • seborrheic dermatitis
  • poison ivy, oak, sumac
  • insect bites
  • soaps and detergents
  • cosmetics
  • jewelry
  • external feminine and anal itching

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
  • apply to affected area not more than 3 to 4 times daily
  • for external anal itching: when practical, clean 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 2 years, or children under 12 years with external anal itching: do not use, ask a doctor

Other information

store at room temperature, protect from freezing

Inactive ingredients

butylated hydroxytoluene, cetyl alcohol, glycerin, glyceryl monostearate, isopropyl myristate, methylparaben, propylparaben, purified water, squalene, and stearic acid

Package label

Best Choice Hydrocortisone Anti-Itch Cream

HYDROCORTISONE 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63941-312
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE 
CETYL ALCOHOL 
GLYCERIN 
GLYCERYL MONOSTEARATE 
ISOPROPYL MYRISTATE 
METHYLPARABEN 
PROPYLPARABEN 
WATER 
SQUALENE 
STEARIC ACID 
Packaging
#Item CodePackage Description
1NDC:63941-312-011 TUBE in 1 BOX
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/29/2012
Labeler - Valu Merchandisers, Co. (868703513)

Revised: 01/2017
 
Valu Merchandisers, Co.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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