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Name:Vagisil Anti Itch Original Strength
Manufacturer:Combe Incorporated
Category:Over-the-counter (OTC) Marketed Drugs


Vagisil Anti Itch Creme

VAGISIL ANTI ITCH ORIGINAL STRENGTH - benzocaine and resorcinol cream 
VAGISIL ANTI ITCH MAXIMUM STRENGTH - benzocaine and resorcinol cream 
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 Creme

Vagisil Anti-Itch Creme Original Strength

Active Ingredients

Benzocaine 5%                                    

Purpose

External analgesic

Active Ingredients

Resorcinol 2%                                    

Purpose

External analgesic

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

Do not apply over large areas of the body

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Directions

  • adults and children 2 years and older: apply a fingertip amount (approximately 1-inch strip) to affected area not more than 3 to 4 times daily
  • children under 2 years: consult a doctor

Inactive ingredients  

water, cetyl alcohol, glyceryl stearate, PEG-100 stearate, mineral oil, isopropyl palmitate, aloe barbadensis leaf juice, tocopheryl acetate, retinyl palmitate, zea mays (corn) oil, cholecalciferol, lanolin alcohol, fragrance, methylparaben, carbomer, isopropyl myristate, isopropyl stearate, sodium sulfite, triethanolamine, trisodium HEDTA



Vagisil Anti-Itch Creme Maximum Strength 

Active Ingredients

Benzocaine 20%                                    

Purpose

External analgesic

Active Ingredients

Resorcinol 3%                                    

Purpose

External analgesic

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

Do not apply over large areas of the body

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: apply a fingertip amount (approximately 1-inch strip) to affected area not more than 3 to 4 times daily
  • children under 12 years: consult a doctor

Inactive ingredients

water, mineral oil, cetyl alcohol, propylene glycol, glyceryl stearate, PEG-100 stearate, isopropyl palmitate, aloe barbadensis leaf juice, tocopheryl acetate, retinyl palmitate, zea mays (corn) oil, cholecalciferol, lanolin alcohol, fragrance, methylparaben, carbomer, isopropyl myristate, isopropyl stearate, sodium sulfite, triethanolamine, trisodium HEDTA

Principal Display Panel

Vagisil®

ANTI-ITCH CREME

ORIGINAL STRENGTH       NET WT. 1 OZ (28 g)

Principal Display Panel - Original Strength 1oz

Principal Display Panel

Vagisil®

ANTI-ITCH CREME

MAXIMUM STRENGTH       NET WT. 1 OZ (28 g)

Principal Display Panel - Maximum Strength 1oz


VAGISIL ANTI ITCH ORIGINAL STRENGTH 
benzocaine and resorcinol cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11509-0360
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOCAINE (BENZOCAINE) BENZOCAINE 50 mg  in 1 g
RESORCINOL (RESORCINOL) RESORCINOL 20 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER  
CETYL ALCOHOL  
GLYCERYL MONOSTEARATE  
POLYOXYL 100 STEARATE  
MINERAL OIL  
ISOPROPYL PALMITATE  
ALOE VERA LEAF  
.ALPHA.-TOCOPHEROL ACETATE, DL-  
CORN OIL  
CHOLECALCIFEROL  
METHYLPARABEN  
ISOPROPYL MYRISTATE  
SODIUM SULFITE  
TROLAMINE  
TRISODIUM HEDTA  
VITAMIN A PALMITATE  
CARBOMER HOMOPOLYMER TYPE C  
Product Characteristics
Color WHITE Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11509-0360-1 1 TUBE (1 TUBE) in 1 CARTON contains a TUBE
1 28 g in 1 TUBE This package is contained within the CARTON (11509-0360-1)
2 NDC:11509-0360-2 1 TUBE (1 TUBE) in 1 CARTON contains a TUBE
2 56 g in 1 TUBE This package is contained within the CARTON (11509-0360-2)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part348 08/01/1974

VAGISIL ANTI ITCH MAXIMUM STRENGTH 
benzocaine and resorcinol cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11509-0372
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOCAINE (BENZOCAINE) BENZOCAINE 200 mg  in 1 g
RESORCINOL (RESORCINOL) RESORCINOL 30 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER  
CETYL ALCOHOL  
GLYCERYL MONOSTEARATE  
POLYOXYL 100 STEARATE  
MINERAL OIL  
ISOPROPYL PALMITATE  
ALOE VERA LEAF  
.ALPHA.-TOCOPHEROL ACETATE, DL-  
CORN OIL  
CHOLECALCIFEROL  
METHYLPARABEN  
ISOPROPYL MYRISTATE  
SODIUM SULFITE  
TROLAMINE  
TRISODIUM HEDTA  
VITAMIN A PALMITATE  
CARBOMER HOMOPOLYMER TYPE C  
PROPYLENE GLYCOL  
Product Characteristics
Color WHITE Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11509-0372-1 1 TUBE (1 TUBE) in 1 CARTON contains a TUBE
1 28 g in 1 TUBE This package is contained within the CARTON (11509-0372-1)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part348 08/01/1974

Labeler - Combe Incorporated (002406502)

Revised: 12/2009 Combe Incorporated



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


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