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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%

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, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis and scrapes
  • 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 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

KEEP OUT OF REACH OF CHILDREN.

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

Directions

  • 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 
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
Ethanol 
methylparaben 
mineral oil 
paraffin 
petrolatum 
propylparaben 
water 
white wax 
Product Characteristics
Colorwhite (white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#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)

 
B8 Sales, Inc.

← See all Hydrocortisone brands

Medically reviewed on Apr 2, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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