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Hydrocortisone by B8 Sales, Inc.

Dosage form: cream
Ingredients: hydrocortisone 10mg in 1g
Labeler: B8 Sales, Inc.
NDC Code: 50607-5802

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.

PIO Put it on®
1% Hydrocortisone Cream™

For Temporary Relief of Itching Associated with Minor Skin Irritations, Inflammation or Rashes

25 Packets

Each Packet Net.Wt.0.9gm

Drug Facts

Active ingredient

Hydrocortisone 1.0%



  • 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, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis and scrapes
  • other uses of this product should be only under the advice and supervision of a doctor

  • For external use only
  • Do not use for the treatment of diaper rash
  • not for external genital, feminine and anal itching

Ask a doctor before use:
  • for external itching, do not exceed the recommended daily dosage, or if bleeding occurs
  • if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days

When using this product
  • avoid contact with eyes
  • do not put this product into rectum or vagina by using fingers or any mechanical device or applicator

Do not use
  • with any other Hydrocortisone product unless you have consulted a doctor • for feminine itching


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


  • for adults and children 2 years of age and older apply
    to affected area 3 to 4 times daily
  • children under 2 years of age: do not use, consult a doctor
  • adults for external anal itching when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with an appropriate cleansing pad
  • gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product

Other information
  • store at room temperature (do not freeze)
  • do not use any opened or torn packets

Inactive ingredients

emulsifying wax, ethanol, methylparaben, mineral oil, paraffin, petrolatum, propylparaben, purified water, white wax

Manufactured for: B8 SALES

Cincinnati,Ohio 45215

Principal Display Panel

1% Hydrocortisone Cream – Carton Label

PIO Put it on®

1% Hydrocortisone Cream™

For Temporary Relief of Itching Associated with Minor Skin Irritations, Inflammation or Rashes

25 Packets

Each Packet Net.Wt.0.9gm

hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50607-5802
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
hydrocortisone (hydrocortisone) hydrocortisone10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
mineral oil 
white wax 
Product Characteristics
Colorwhite (white) Score    
FlavorImprint Code
#Item CodePackage Description
1NDC:50607-5802-125 POUCH (25 POUCH) in 1 BOX
1.9 g in 1 POUCH
2NDC:50607-5802-2144 POUCH (144 POUCH) in 1 BOX
2.9 g in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34705/01/2010
Labeler - B8 Sales, Inc. (833208635)

Revised: 04/2010
B8 Sales, Inc.

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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.