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VAGISIL Anti-Itch Medicated Wipes Maximum Strength

Medically reviewed on February 7, 2018

Dosage form: cloth
Ingredients: PRAMOXINE HYDROCHLORIDE 10mg in 1g
Labeler: Combe Incorporated
NDC Code: 11509-5035

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 Anti-Itch Medicated Wipes Maximum Strength

VAGISIL Anti-Itch Medicated Wipes

Drug Facts

Active ingredient

Pramoxine Hydrochloride 1% (w/w)

Purpose

External analgesic

Use

Temporarily relieves itching

Warnings

For external use only

Avoid contact with eyes

Stop use and ask 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 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 yearsconsult a doctor

Inactive ingredients

water, polysorbate 20, glycerin, phenoxyethanol, disodium cocoamphodiacetate, TEA-cocoyl glutamate, ethylparaben, disodium EDTA, methylparaben, fragrance, PEG-7 glyceryl cocoate, aloe barbadensis leaf extract, tocopheryl acetate, maltodextrin

VAGISIL Anti-Itch Medicated Wipes

Drug Facts

Active ingredient

Pramoxine Hydrochloride 1% (w/w)

Purpose

External analgesic

Use

Temporarily relieves itching

Warnings

For external use only

Avoid contact with eyes

Stop use and ask 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 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 yearsconsult a doctor

Other information

Store at room temperature

Discard within 2 months of opening

Inactive ingredients

water, polysorbate 20, glycerin, phenoxyethanol, disodium cocoamphodiacetate, TEA-cocoyl glutamate, ethylparaben, disodium EDTA, methylparaben, fragrance, PEG-7 glyceryl cocoate, aloe barbadensis leaf extract, tocopheryl acetate, maltodextrin

Principal Display Panel

Maximum Strength
Vagisil
®

Anti-Itch Medicated Wipes

Instant Relief From Intense Itch

Gynocologist Tested

Clinically Tested

Triple-Action Itch Relief

Wipes Away Intense Itch On Contact

Soothes and Cleanses Skin

Patented Odor Block Technology

12 individually wrapped disposable wipes

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

Principal Display Panel

Vagisil®
Maximum Strength

Anti-Itch Medicated Wipes

Clinically Tested

Instant Relief From Intense Itch

Triple-Action Relief

Wipes Away Intense Itch On Contact
20 soft, disposable wipes

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

VAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH 
pramoxine hydrochloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11509-5035
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 
TRIETHANOLAMINE COCOYL GLUTAMATE 
ETHYLPARABEN 
EDETATE DISODIUM 
METHYLPARABEN 
PEG-7 GLYCERYL COCOATE 
ALOE VERA LEAF 
.ALPHA.-TOCOPHEROL ACETATE, DL- 
MALTODEXTRIN 
Packaging
#Item CodePackage Description
1NDC:11509-5035-112 PACKET in 1 CARTON
14.5 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34706/28/2005
VAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH 
pramoxine hydrochloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11509-5058
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 
TRIETHANOLAMINE COCOYL GLUTAMATE 
ETHYLPARABEN 
EDETATE DISODIUM 
METHYLPARABEN 
PEG-7 GLYCERYL COCOATE 
ALOE VERA LEAF 
.ALPHA.-TOCOPHEROL ACETATE, DL- 
MALTODEXTRIN 
Packaging
#Item CodePackage Description
1NDC:11509-5058-120 PACKET in 1 POUCH
13.4 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(11509-5035, 11509-5058)

 
Combe Incorporated

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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