Vagisil Anti-Itch Creme Maximum Strength Sensitive Skin Formula: Package Insert and Label Information

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.

Vagisil Sensitive Skin A nti-Itch Cr e me

Drug Facts

Active i ngredient s

Hydrocortisone Acetate 1%

Purpose

Anti-itch

Use

For temporary external feminine itching.

Warnings

For e xternal u se o nly

Avoid c ontact 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 i ngredients:

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 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 Type HUMAN OTC DRUG Item Code (Source) NDC:11509-5101
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE ACETATE (HYDROCORTISONE) HYDROCORTISONE ACETATE 280 mg in 28 g
Inactive Ingredients
Ingredient Name Strength
WATER
CETYL ETHYLHEXANOATE
GLYCERIN
POLYOXYL 40 HYDROGENATED CASTOR OIL
GLYCERYL DILAURATE
DIMETHICONE
OATMEAL
ALOE VERA LEAF
SODIUM POLYACRYLATE (2500000 MW)
CAPRYLYL GLYCOL
POLYOXYL 20 CETOSTEARYL ETHER
GLYCERYL OLEATE
CARBOMER INTERPOLYMER TYPE A (55000 CPS)
CYCLOMETHICONE 5
TRIDECETH-6
SODIUM HYDROXIDE
EDETATE DISODIUM
SORBIC ACID
PEG/PPG-18/18 DIMETHICONE
ALPHA-TOCOPHEROL ACETATE
MALTODEXTRIN
PHENOXYETHANOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11509-5101-1 28 g in 1 CARTON None
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)

Revised: 04/2020 Combe Incorporated

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