MONISTAT COMPLETE CARE INSTANT ITCH RELIEF- hydrocortisone cream

Monistat Complete Care Instant Itch Relief by

Drug Labeling and Warnings

Monistat Complete Care Instant Itch Relief by is a Otc medication manufactured, distributed, or labeled by Insight Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

• temporarily relieves external genital itching
  
• other uses of this product should only be under the advice and supervision of a doctor

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

• adults: apply to affected area not more than 3-4 times daily
  
• children under 12 years of age: ask a doctor

Other Information

• store at 20°-25°C (68°-77°F). Protect from freezing and excessive heat.

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)

INGREDIENTS AND APPEARANCE

MONISTAT COMPLETE CARE INSTANT ITCH RELIEF 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63736-029
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63736-029-01	1 in 1 CARTON	11/15/2013
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	11/15/2013

Labeler - Insight Pharmaceuticals LLC (055665422)