HYDROCORTISONE- hydrocortisone cream 
Central Texas Community Health Centers

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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Hydrocortisone

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:

Other uses of this product should be 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 immediately.

Directions

Adults and children 2 years of age and older

Children under 2 years of age

For external anal itching

Other information

You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.

Inactive ingredients

cetyl alcohol, diazolidinyl urea, isopropyl palmitate, mineral oil/lanolin alcohol, polysorbate 40, propylene glycol, propylene glycol monostearate, purified water, sorbic acid, sorbitan monopalmitate, stearyl alcohol, xanthan gum

Made in the USA
for Qualitest Pharmaceuticals
Huntsville, AL 35811

Rev. 5/15 R6
8265556  0534

PRINCIPAL DISPLAY PANEL - 28 g Tube Label

CommUnityCare Federally Qualified Health Centers

HYDROCORTISONE
1% CR 28g

Date:

Name:
Dr.

USE AS DIRECTED.

123456

1/1/01

HYDROCORTISONE 1% CRM 30G NDC 76413-311-30

Batch: 123456
Lot: 123456
Exp: 1/1/01
QUALITEST

Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.

Principal Display Panel - 28 g Tube Label
HYDROCORTISONE 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76413-311(NDC:0603-0535)
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
CETYL ALCOHOL (UNII: 936JST6JCN)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
MINERAL OIL (UNII: T5L8T28FGP)  
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
POLYSORBATE 40 (UNII: STI11B5A2X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLENE GLYCOL MONOSTEARATE (UNII: MZM1I680W0)  
WATER (UNII: 059QF0KO0R)  
SORBIC ACID (UNII: X045WJ989B)  
SORBITAN MONOPALMITATE (UNII: 77K6Z421KU)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76413-311-301 in 1 CARTON10/01/2001
128.4 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34810/01/2001
Labeler - Central Texas Community Health Centers (079674019)
Establishment
NameAddressID/FEIBusiness Operations
Central Texas Community Health Centers079674019REPACK(76413-311) , RELABEL(76413-311)

Revised: 4/2016
Document Id: 95e16d23-158c-44bc-9bb9-adea5037a4d3
Set id: fbb876c0-a026-4eec-ae3e-f1d61c4661de
Version: 1
Effective Time: 20160408
 
Central Texas Community Health Centers