MONISTAT COMPLETE CARE INSTANT ITCH RELIEF- hydrocortisone cream 
Insight Pharmaceuticals LLC

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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Monistat Care Itch Relief Cream

Drug Facts

Active Ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

Warnings

For external use only

Ask a doctor before use if

you have a vaginal discharge

When using this product

  • avoid contact with eyes
  • do not use more than directed
  • do not begin use of any other hydrocortisone product unless you have asked a doctor

Stop use and ask a doctor if

  • condition worsens
  • symptoms last for more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

If swallowed get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Other Information

Inactive ingredients

ammonium acryloyldimethyltaurate/VP copolymer, carbomer, ceteareth-6, cetyl alcohol, citric acid, dimethicone, edetate disodium, ethylparaben, glycerin, methylparaben, mineral oil, petrolatum, phenoxyethanol, propylparaben, sodium citrate, sodium hydroxide, stearyl alcohol, VP/eicosene copolymer, water

Questions?

1-877-666-4782 Monistat.com

Dist. by Insight Pharmaceuticals, LLC. 
Tarrytown, NY 10591

A Prestige Brands Company

PRINCIPAL DISPLAY PANEL

MONISTAT® 

Care

Itch Relief Cream

Hydrocortisone 1%

NEW WT 1 OZ (28 g)

PRINCIPAL DISPLAY PANEL

MONISTAT® 
Care
Itch Relief Cream
Hydrocortisone 1%

NEW WT 1 OZ (28 g)

MONISTAT COMPLETE CARE INSTANT ITCH RELIEF 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-029
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
CARBOMER HOMOPOLYMER TYPE A (UNII: F68VH75CJC)  
CETEARETH-6 (UNII: 2RJS3559D3)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ETHYLPARABEN (UNII: 14255EXE39)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
WATER (UNII: 059QF0KO0R)  
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63736-029-011 in 1 CARTON11/15/2013
128 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 FINALpart34811/15/2013
Labeler - Insight Pharmaceuticals LLC (055665422)

Revised: 3/2018
Document Id: 5dfa37c9-ffd8-4506-ade3-da6ecac2044f
Set id: a0f40504-6183-4f32-8d17-6586b3f386a6
Version: 2
Effective Time: 20180306
 
Insight Pharmaceuticals LLC