Your browser does not support JavaScript! VAGISIL ANTI ITCH ORIGINAL STRENGTH (BENZOCAINE AND RESORCINOL) CREAM VAGISIL ANTI ITCH MAXIMUM STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [COMBE INCORPORATED]
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RxNorm Names

VAGISIL ANTI ITCH ORIGINAL STRENGTH (benzocaine and resorcinol) cream
VAGISIL ANTI ITCH MAXIMUM STRENGTH (benzocaine and resorcinol) cream
[Combe Incorporated]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

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 DRUG LABELItem Code (Source)NDC:11509-0360
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE50 mg  in 1 g
RESORCINOL (RESORCINOL) RESORCINOL20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11509-0360-11 in 1 CARTON
128 g in 1 TUBE
2NDC:11509-0360-21 in 1 CARTON
256 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34808/01/1974
VAGISIL ANTI ITCH MAXIMUM STRENGTH 
benzocaine and resorcinol cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:11509-0372
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE200 mg  in 1 g
RESORCINOL (RESORCINOL) RESORCINOL30 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11509-0372-11 in 1 CARTON
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34808/01/1974
Labeler - Combe Incorporated (002406502)

Revised: 12/2009
 
Combe Incorporated

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