VAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH- 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 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. Do not flush.
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 Maximum Strength Medicated Anti-Itch 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. Do not flush.
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®

Medicated Anti-Itch Wipes

Instant Relief From Intense Itch

Gynecologist Tested

Clinically Tested

12 individually wrapped disposable wipes

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

Maximum Strength Vagisil® Medicated Anti-Itch Wipes Instant Relief From Intense Itch Gynecologist Tested Clinically Tested • On-the-go relief • With Aloe & Vitamin E • 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

Medicated Anti-Itch Wipes

Gynecologist Tested

Instant Relief From Intense Itch

20 soft, disposable wipes

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

Principal Display Panel Vagisil® Maximum Strength Medicated Anti-Itch Wipes Gynecologist Tested Instant Relief From Intense Itch • With Aloe & Vitamin E • Patented Odor Block Technology 20 soft, disposable wipes 5 in. x 7.28 in. (12.7 cm x 18.5 cm)

Vagisil® Maximum Strength Medicated Anti-Itch Wipes Gynecologist Tested Instant Relief From Intense Itch • With Aloe & Vitamin E • Patented Odor Block Technology 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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
TRIETHANOLAMINE COCOYL GLUTAMATE (UNII: LA19WH54UL)  
ETHYLPARABEN (UNII: 14255EXE39)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11509-5035-112 in 1 CARTON06/28/2005
14.5 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34806/28/2005
VAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH 
pramoxine hydrochloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11509-5058
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
TRIETHANOLAMINE COCOYL GLUTAMATE (UNII: LA19WH54UL)  
ETHYLPARABEN (UNII: 14255EXE39)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11509-5058-120 in 1 POUCH06/28/2005
13.4 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34806/28/2005
Labeler - Combe Incorporated (002406502)
Establishment
NameAddressID/FEIBusiness Operations
Combe Laboratories, Inc.808100197ANALYSIS(11509-5035, 11509-5058) , LABEL(11509-5035, 11509-5058) , MANUFACTURE(11509-5035, 11509-5058) , PACK(11509-5035, 11509-5058)

Revised: 4/2020
Document Id: 2a24ec3c-4966-4804-aa26-4ddab397afaa
Set id: b848f53d-8aea-4efe-aa2c-009d5121fc33
Version: 8
Effective Time: 20200420
 
Combe Incorporated