HYDROCORTISONE- hydrocortisone cream 
B8 Sales, Inc.

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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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

Warnings

Ask a doctor before use:

When using this product

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

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

1% Hydrocortisone Cream – Carton Label
HYDROCORTISONE 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50607-5802
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
Ethanol (UNII: 3K9958V90M)  
methylparaben (UNII: A2I8C7HI9T)  
mineral oil (UNII: T5L8T28FGP)  
paraffin (UNII: I9O0E3H2ZE)  
petrolatum (UNII: 4T6H12BN9U)  
propylparaben (UNII: Z8IX2SC1OH)  
water (UNII: 059QF0KO0R)  
white wax (UNII: 7G1J5DA97F)  
Product Characteristics
Colorwhite (white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50607-5802-125 in 1 BOX
1.9 g in 1 POUCH
2NDC:50607-5802-2144 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: 4/2010
Document Id: 9fa5a9a0-ed3b-4d00-8f8f-bd91076f587c
Set id: a5c30b44-9a6b-478f-9b2c-c71ba63c04e4
Version: 1
Effective Time: 20100402
 
B8 Sales, Inc.