HYDROCORTISONE ULTRA STRENGTH- hydrocortisone cream 
Personal Care Products, 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

Drug Facts

Hydrocortisone 1%

Purpose

Anti itch

Keep out of reach of children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Uses

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

Warnings

For external use only

Do not use


When using this product


Stop use and ask a doctor if

Directions

Other information

Inactive ingredients

aloe vera gel, celeareth-20, cetyl alcohol, cetyl palitate, glycerin, isopropyl myristate, isodecyl neopentanoate, methyl paraben, purified water

Product Label

DRUGSTORE-Rx

SMART WELLNESS

Ultra Strength

Hydrocortisone Cream

Fast Itch and Rash relief

Helps relieve


NET WT. 0.5 OZ. (14 g)

Distributed by: PERSONAL CARE PRODUCTS, LLC  Troy, Michigan 48084 U.S.A.

Code No.:MH/DRUGS/KD-313      Made in India


PC Hydrocortisone1 Label

PC Hydrocortisone4 Label







HYDROCORTISONE  ULTRA STRENGTH
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29500-2439
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE140 mg  in 14 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CETYL PALMITATE (UNII: 5ZA2S6B08X)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:29500-2439-114 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/10/2013
Labeler - Personal Care Products, Inc. (966155082)
Registrant - Personal Care Products, Inc. (966155082)
Establishment
NameAddressID/FEIBusiness Operations
Anicare Pharmaceuticals Pvt. Ltd.916837425manufacture(29500-2439)

Revised: 7/2013
Document Id: 328f2e5f-41e1-474e-8f3a-e44281048e61
Set id: f47b3ed9-a2db-4856-84e2-fafe12a22988
Version: 1
Effective Time: 20130710
 
Personal Care Products, Inc.