Vagisil Satin

Dosage form: cream
Ingredients: HYDROCORTISONE ACETATE 10mg in 1g
Labeler: Combe Incorporated
NDC Code: 11509-0362

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

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)

VAGISIL SATIN 
hydrocortisone acetate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11509-0362
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE ACETATE (HYDROCORTISONE) HYDROCORTISONE ACETATE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERIN 
POLYOXYL 40 HYDROGENATED CASTOR OIL 
PHENOXYETHANOL 
DIMETHICONE 
GLYCERYL MONOOLEATE 
METHYLPARABEN 
TROLAMINE 
CYCLOMETHICONE 5 
ETHYLPARABEN 
EDETATE DISODIUM 
.ALPHA.-TOCOPHEROL ACETATE, DL- 
CORN OIL 
VITAMIN A PALMITATE 
CHOLECALCIFEROL 
ALOE VERA LEAF 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:11509-0362-11 BOTTLE, PUMP (1 BOTTLE) in 1 CARTON
128 g in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34804/15/2008
Labeler - Combe Incorporated (002406502)
Establishment
NameAddressID/FEIOperations
Combe Products, Inc.091123992MANUFACTURE

Revised: 12/2009
 
Combe Incorporated

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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