VAGISIL SATIN- 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 Satin

Active Ingredients

Hydrocortison acetate 1%

Purpose

External Analgesic

Use

temporarily relieves itching associated with minor skin irritation, inflammation and rashes due to

▪ external feminine itching

▪ anal itching

Warnings

For external use only

Avoid contact with eyes

Stop use, do not use any hydrocortisone product, and ask a doctor if

▪ condition worsens

▪ symptoms last more than 7 days or clear up and occur again within a few days

Do not use

if you have vaginal discharge without consulting a doctor

Do not use

for the treatment of diaper rash without consulting a doctor

When using this product for anal itching

▪ do not exceed the recommended daily dosage unless directed by a doctor

▪ in case of bleeding, consult a doctor promptly

▪ do not put this product in the rectum by using fingers, a mechanical device or applicator.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center immediately

Directions

▪ for external feminine itching

▪ adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily

▪ children under 2 years: do not use; ask a doctor

▪ for anal itching

▪ adults and children 12 years and older: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly; gently dry by patting or blotting with toilet tissue or soft cloth before application of this product; apply to affected area not more than 3 to 4 times daily

▪ children under 12 years: ask a doctor

Inactive ingredients

water, cetyl ethylhexanoate, glycerin, PEG-40 hydrogenated castor oil, glyceryl dilaurate, phenoxyethanol, sodium polyacrylate, dimethicone, ceteareth-20, glyceryl oleate, methylparaben, triethanolamine, acrylates/C10-30 alkyl acrylates crosspolymer, cyclopentasiloxane, fragrance, ethylparaben, trideceth-6, disodium EDTA, PEG/PEG-18/18 dimethicone, tocopheryl (vitamin E) acetate, zea mays (corn) oil, retinyl palmitate (vitamin A) acetate, cholecalciferol (vitamin D3), aloe barbadensis

Principal Display Panel

Vagisil

Satin TM

1% Hydrocortison Acetate Creme

anti-itch creme for

ALL-DAY COMFORT

Light, non-greasy
Patented Odor Block
protection

NET WT. 1 OZ (28 g)

Principal Display Panel - 1oz

VAGISIL SATIN
hydrocortisone acetate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11509-0362
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE ACETATE	10 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERYL OLEATE (UNII: 4PC054V79P)
METHYLPARABEN (UNII: A2I8C7HI9T)
TROLAMINE (UNII: 9O3K93S3TK)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ETHYLPARABEN (UNII: 14255EXE39)
EDETATE DISODIUM (UNII: 7FLD91C86K)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
CORN OIL (UNII: 8470G57WFM)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11509-0362-1	1 in 1 CARTON	04/15/2008	08/11/2011
1		28 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part348	04/15/2008	08/11/2011

Labeler - Combe Incorporated (002406502)

Name	Address	ID/FEI	Business Operations
Establishment
Combe Products, Inc.		091123992	MANUFACTURE(11509-0362)

Revised: 2/2017

Document Id: 0fdf3f24-2999-4faa-bee3-0cb4ff847336

Set id: e6ee8f26-c9e5-474d-980b-4ef40c15ba18

Version: 4

Effective Time: 20170227

Combe Incorporated