Label: MONISTAT COMPLETE CARE INSTANT ITCH RELIEF- hydrocortisone cream
- NDC Code(s): 63736-029-01
- Packager: Insight Pharmaceuticals LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated March 6, 2018
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Uses
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Warnings
For external use only
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
- avoid contact with eyes
- Directions
- Other Information
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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
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INGREDIENTS AND APPEARANCE
MONISTAT COMPLETE CARE INSTANT ITCH RELIEF
hydrocortisone creamProduct 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)