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


Vagisil Medicated Wipes

VAGISIL MEDICATED WIPES - pramoxine hydrochloride cloth 
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 Medicated Wipes

Vagisil Anti-Itch Medicated Wipes

Active Ingredients

Pramoxine hydrochloride 1% w/w                  

Purpose

External analgesic towelette

Use

  • temporarily relieves 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

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 of age and older: unfold towelette and gently pat or wipe external vaginal area from front to back. Use each towelette only once and then throw away. Apply to affected area not more than 3 to 4 times daily.
  • children under 12 years: consult a doctor

Inactive Ingredient

water, polysorbate 20, glycerin, phenoxyethanol, disodium cocoamphodiacetate, TEA-cocoyl glutamate, methylparaben, Fragrance, Ethylparaben, disodium EDTA, PEG-7 glyceryl cocoate, aloe barbadensis leaf juice, tocopheryl (Vitamin E) acetate, zea mays (corn) oil, retinyl (Vitamin A) palmitate, cholecalciferol (Vitamin D),

Principal Display Panel

INSTANT RELIEF

from intense itch

Vagisil® 

1% Pramoxine hydrochloride      

ANTI-ITCH MEDICATED

MAXIMUM STRENGTH WIPES

12 individually wrapped, flushable wipes

5 in. x 7.28 in. (12.7 cm x 18.5 cm)

  • patented Odor Block protection
  • cleanses while relieving itch

Principal Display Panel - 12 Count Carton


VAGISIL MEDICATED WIPES 
pramoxine hydrochloride cloth
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11509-0375
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE 10 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER  
POLYSORBATE 20  
GLYCERIN  
PHENOXYETHANOL  
DISODIUM COCOAMPHODIACETATE  
METHYLPARABEN  
ETHYLPARABEN  
EDETATE DISODIUM  
ALOE VERA LEAF  
.ALPHA.-TOCOPHEROL ACETATE, DL-  
CORN OIL  
VITAMIN A PALMITATE  
CHOLECALCIFEROL  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11509-0375-1 12 PACKET (12 PACKET) in 1 CARTON contains a PACKET
1 4.7 g in 1 PACKET This package is contained within the CARTON (11509-0375-1)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part347 06/28/2005

VAGISIL MEDICATED WIPES 
pramoxine hydrochloride cloth
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11509-0376
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE 10 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER  
POLYSORBATE 20  
GLYCERIN  
PHENOXYETHANOL  
DISODIUM COCOAMPHODIACETATE  
METHYLPARABEN  
ETHYLPARABEN  
EDETATE DISODIUM  
ALOE VERA LEAF  
.ALPHA.-TOCOPHEROL ACETATE, DL-  
CORN OIL  
VITAMIN A PALMITATE  
CHOLECALCIFEROL  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11509-0376-1 20 PACKET (20 PACKET) in 1 POUCH contains a PACKET
1 4.7 g in 1 PACKET This package is contained within the POUCH (11509-0376-1)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part347 06/28/2005

Labeler - Combe Incorporated (002406502)
Establishment
Name Address ID/FEI Operations
Combe Laboratories, Inc. 808100197 MANUFACTURE

Revised: 02/2011 Combe Incorporated



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


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