VAGISIL ANTI-ITCH MEDICATED CREME 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 Medicated Creme

VAGISIL Maximum Strength Anti-Itch Creme

Drug Facts

Active ingredient

Benzocaine 20%

Purpose

External analgesic

Active ingredient

Resorcinol 3%

Purpose

External analgesic

Use

temporarily relieves itching

Warnings

For external use only

Allergy Allert

Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other –caine anesthetics.

Avoid contact with eyes

in case of contact rinse thoroughly and immediately with water.

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          

Apply a fingertip amount (approximately 1-inch strip) to affected area not more than 3 to 4 times daily. Clean nozzle of tube by wiping thoroughly before replacing cap. Keep cap tightly closed between uses.
children under 12 yearsconsult a doctor

Other Information:

questions? call 1-800-431-2610, 9 am to 5 pm est

Inactive ingredients

Water, Mineral Oil, Cetyl Alcohol, Propylene Glycol, Glyceryl Stearate, PEG-100 Stearate, Isopropyl Palmitate, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate, Retinyl Palmitate, Zea Mays (Corn) Oil, Cholecalciferol, Lanolin Alcohol, Fragrance, Methylparaben, Carbomer, Isopropyl Myristate, Isopropyl Stearate, Sodium Sulfite, Triethanolamine, Trisodium HEDTA, Maltodextrin

Principal Display Panel

Vagisil®
Maximum Strength
Anti-Itch Creme

Net Wt. 1 oz. (28 g)

Principal Display Panel
Vagisil®
Maximum Strength
Anti-Itch Creme
Net Wt. 1 oz. (28 g)

VAGISIL ANTI-ITCH MEDICATED CREME MAXIMUM STRENGTH 
benzocaine and resorcinol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11509-4402
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)  
MINERAL OIL (UNII: T5L8T28FGP)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
POLYOXYL 100 STEARATE (UNII: YD01N1999R)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
CORN OIL (UNII: 8470G57WFM)  
CHOLECALCIFEROL (UNII: 1C6V77QF41)  
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
ISOPROPYL STEARATE (UNII: 43253ZW1MZ)  
SODIUM SULFITE (UNII: VTK01UQK3G)  
TROLAMINE (UNII: 9O3K93S3TK)  
TRISODIUM HEDTA (UNII: K3E0U7O8KI)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11509-4402-11 in 1 CARTON03/01/1995
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 FINALpart34803/01/1995
Labeler - Combe Incorporated (002406502)

Revised: 11/2020
Document Id: 132b129e-9640-4a5b-9e4d-8f3d5b90331b
Set id: bb73ebd7-ceb0-4b54-9e8f-77486d9037fb
Version: 8
Effective Time: 20201123
 
Combe Incorporated