VAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH- pramoxine hydrochloride cloth

VAGISIL Anti-Itch Medicated Wipes Maximum Strength by

Drug Labeling and Warnings

VAGISIL Anti-Itch Medicated Wipes Maximum Strength by is a Otc medication manufactured, distributed, or labeled by Combe Incorporated, Combe Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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 children12 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 years: consult 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

SPL UNCLASSIFIED SECTION

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 children12 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 years: consult 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

• 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

• 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)

INGREDIENTS AND APPEARANCE

VAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH 
pramoxine hydrochloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11509-5035
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11509-5035-1	12 in 1 CARTON	06/28/2005
1		4.5 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	06/28/2005

VAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH 
pramoxine hydrochloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11509-5058
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11509-5058-1	20 in 1 POUCH	06/28/2005
1		3.4 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	06/28/2005

Labeler - Combe Incorporated (002406502)

Establishment
Name	Address	ID/FEI	Business Operations
Combe Laboratories, Inc.		808100197	ANALYSIS(11509-5035, 11509-5058) , LABEL(11509-5035, 11509-5058) , MANUFACTURE(11509-5035, 11509-5058) , PACK(11509-5035, 11509-5058)