Vagisil Medicated Wipes

Dosage form: cloth
Ingredients: PRAMOXINE HYDROCHLORIDE 10mg in 1g
Labeler: Combe Incorporated
NDC Code: 11509-0375

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 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

VAGISIL MEDICATED WIPES 
pramoxine hydrochloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11509-0375
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
POLYSORBATE 20 
GLYCERIN 
PHENOXYETHANOL 
DISODIUM COCOAMPHODIACETATE 
METHYLPARABEN 
ETHYLPARABEN 
EDETATE DISODIUM 
ALOE VERA LEAF 
.ALPHA.-TOCOPHEROL ACETATE, DL- 
CORN OIL 
VITAMIN A PALMITATE 
CHOLECALCIFEROL 
Packaging
#Item CodePackage Description
1NDC:11509-0375-112 PACKET (12 PACKET) in 1 CARTON
14.7 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34706/28/2005
VAGISIL MEDICATED WIPES 
pramoxine hydrochloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11509-0376
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
POLYSORBATE 20 
GLYCERIN 
PHENOXYETHANOL 
DISODIUM COCOAMPHODIACETATE 
METHYLPARABEN 
ETHYLPARABEN 
EDETATE DISODIUM 
ALOE VERA LEAF 
.ALPHA.-TOCOPHEROL ACETATE, DL- 
CORN OIL 
VITAMIN A PALMITATE 
CHOLECALCIFEROL 
Packaging
#Item CodePackage Description
1NDC:11509-0376-120 PACKET (20 PACKET) in 1 POUCH
14.7 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34706/28/2005
Labeler - Combe Incorporated (002406502)
Establishment
NameAddressID/FEIOperations
Combe Laboratories, Inc.808100197MANUFACTURE

Revised: 02/2011
 
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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