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

Vagisil Anti-Itch Creme Maximum Strength Sensitive Skin Formula by

Drug Labeling and Warnings

Vagisil Anti-Itch Creme Maximum Strength Sensitive Skin Formula by is a Otc medication manufactured, distributed, or labeled by Combe Incorporated. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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 older: Apply to external vaginal area not more than 3 to 4 times a day
• children under 12 years: consult 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)

INGREDIENTS AND APPEARANCE

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

Product 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)