Label: VAGISIL ANTI-ITCH CREME MAXIMUM STRENGTH SENSITIVE SKIN FORMULA- hydrocortisone acetate cream
- NDC Code(s): 11509-5101-1
- Packager: Combe Incorporated
- 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 April 20, 2020
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- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
- Use
- Warnings
- Directions
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Inactive ingredients:
water, cetyl ethylhexanoate, glycerin, PEG-40 hydrogenated castor oil, glyceryl dilaurate, dimethicone, colloidal oatmeal, aloe barbadensis leaf extract, sodium polyacrylate, caprylyl glycol, ceteareth-20, glyceryl oleate, acrylates/C10-30 alkyl acrylate crosspolymer, cyclopentasiloxane, trideceth-6, sodium hydroxide, disodium EDTA, sorbic acid, PEG/PPG-18/18 dimethicone, tocopheryl acetate, maltodextrin, phenoxyethanol.
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INGREDIENTS AND APPEARANCE
VAGISIL ANTI-ITCH CREME MAXIMUM STRENGTH SENSITIVE SKIN FORMULA
hydrocortisone acetate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11509-5101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE 280 mg in 28 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CETYL ETHYLHEXANOATE (UNII: 134647WMX4) GLYCERIN (UNII: PDC6A3C0OX) POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) GLYCERYL DILAURATE (UNII: MFL3ZIE8SK) DIMETHICONE (UNII: 92RU3N3Y1O) OATMEAL (UNII: 8PI54V663Y) ALOE VERA LEAF (UNII: ZY81Z83H0X) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) CAPRYLYL GLYCOL (UNII: 00YIU5438U) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) GLYCERYL OLEATE (UNII: 4PC054V79P) CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) TRIDECETH-6 (UNII: 3T5PCR2H0C) SODIUM HYDROXIDE (UNII: 55X04QC32I) EDETATE DISODIUM (UNII: 7FLD91C86K) SORBIC ACID (UNII: X045WJ989B) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) MALTODEXTRIN (UNII: 7CVR7L4A2D) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11509-5101-1 28 g in 1 CARTON; Type 0: Not a Combination Product 01/30/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part348 01/30/2016 Labeler - Combe Incorporated (002406502)