VAGISIL ANTI-ITCH CREME MAXIMUM STRENGTH SENSITIVE SKIN FORMULA- hydrocortisone acetate cream 
Combe Incorporated

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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Vagisil Anti-Itch Crème Maximum Strength, Sensitive Skin Formula

Vagisil Sensitive Skin Anti-Itch Creme 

Drug Facts

Active ingredients

Hydrocortisone Acetate 1%

Purpose

Anti-itch

Use

For temporary external feminine itching.

Warnings

For external use only

Avoid contact with eyes

Stop use and ask a doctor if

condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days.

Do not use if 

you have a vaginal discharge. Consult a physician.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children 12 years and olderApply to external vaginal area not more than 3 to 4 times a day
children under 12 yearsconsult a doctor

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.

PRINCIPAL DISPLAY PANEL

Vagisil Sensitive Skin Anti-Itch Creme, 1% Hydrocortisone
Net. Wt. 1 oz. (28 g)

Vagisil Sensitive Skin Anti-Itch Creme, 1% Hydrocortisone
Net. Wt. 1 oz. (28 g)

VAGISIL ANTI-ITCH CREME MAXIMUM STRENGTH SENSITIVE SKIN FORMULA 
hydrocortisone acetate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11509-5101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE280 mg  in 28 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11509-5101-128 g in 1 CARTON; Type 0: Not a Combination Product01/30/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34801/30/2016
Labeler - Combe Incorporated (002406502)

Revised: 4/2020
Document Id: d70e4063-6d69-489d-8052-fe5c311a717e
Set id: 9b69fa24-02dd-43e4-a81f-9a37968d7099
Version: 3
Effective Time: 20200420
 
Combe Incorporated