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.

----------

Vagisil Anti-Itch Original Strength and Maximum Strength

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:11509-0360
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE50 mg  in 1 g
RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK) RESORCINOL20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
POLYOXYL 100 STEARATE (UNII: YD01N1999R)  
MINERAL OIL (UNII: T5L8T28FGP)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
CORN OIL (UNII: 8470G57WFM)  
CHOLECALCIFEROL (UNII: 1C6V77QF41)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
SODIUM SULFITE (UNII: VTK01UQK3G)  
TROLAMINE (UNII: 9O3K93S3TK)  
TRISODIUM HEDTA (UNII: K3E0U7O8KI)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11509-0360-11 in 1 CARTON08/01/197412/31/2010
128 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:11509-0360-21 in 1 CARTON08/01/197412/31/2010
256 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34808/01/197412/31/2010
VAGISIL ANTI ITCH MAXIMUM STRENGTH 
benzocaine and resorcinol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11509-0372
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK) RESORCINOL30 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
POLYOXYL 100 STEARATE (UNII: YD01N1999R)  
MINERAL OIL (UNII: T5L8T28FGP)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
CORN OIL (UNII: 8470G57WFM)  
CHOLECALCIFEROL (UNII: 1C6V77QF41)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
SODIUM SULFITE (UNII: VTK01UQK3G)  
TROLAMINE (UNII: 9O3K93S3TK)  
TRISODIUM HEDTA (UNII: K3E0U7O8KI)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11509-0372-11 in 1 CARTON08/01/197412/31/2010
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34808/01/197412/31/2010
Labeler - Combe Incorporated (002406502)

Revised: 2/2019
 
Combe Incorporated