BUDPAK ANTI-ITCH- hydrocortisone cream 
Budpak 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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Active Ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

for the temporary relief of itching associated with minor skin irritations and rashes due to:

Other uses or the use of the product for more than 7 days should be undertaken only under the advice and supervision of a doctor.

Warnings

For external use only

Do not use

When using this product

Stop use and ask a doctor if

Keep out of reach of children.

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

Directions

for itching of skin irritation, inflammation, and rashes:

for external anal and genital itching, adults:

Other information

Inactive Ingredients

Purified Water, Mineral Oil, Propylene Glycol, Cetearyl Alcohol, Petrolatum, Glyceryl Stearate, Polysorbate 60, Sorbitan Stearate, Methylparaben, Propylparaben, Disodium Edta

PRINCIPAL DISPLAY PANEL

BUDPAK ANTI-ITCH CREAM

Hydrocortisone 1%

NET WT 0.5 OZ. (14 g)

image of package label

BUDPAK ANTI-ITCH 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27293-017
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE0.01 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
MINERAL OIL (UNII: T5L8T28FGP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
PETROLATUM (UNII: 4T6H12BN9U)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
EDETATE SODIUM (UNII: MP1J8420LU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:27293-017-011 in 1 BOX
1NDC:27293-017-1414 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/17/2012
Labeler - Budpak Inc. (183224849)
Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
Establishment
NameAddressID/FEIBusiness Operations
Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(27293-017)

Revised: 1/2013
Document Id: 1d91f27f-8cf0-4af1-a049-c74835d6859b
Set id: 0a67e5e7-fc2e-445e-a5c6-03d07c91f29c
Version: 1
Effective Time: 20130104
 
Budpak Inc.