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Name:Vagisil Satin
Manufacturer:Combe Incorporated
Category:Over-the-counter (OTC) Marketed Drugs


Vagisil Satin

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.

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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)

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 DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE ACETATE (HYDROCORTISONE) HYDROCORTISONE ACETATE 10 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
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
Color WHITE Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11509-0362-1 1 BOTTLE, PUMP (1 BOTTLE) in 1 CARTON contains a BOTTLE, PUMP
1 28 g in 1 BOTTLE, PUMP This package is contained within the CARTON (11509-0362-1)

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

Labeler - Combe Incorporated (002406502)
Establishment
Name Address ID/FEI Operations
Combe Products, Inc. 091123992 MANUFACTURE

Revised: 12/2009 Combe Incorporated



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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