VAGI-CURE ADVANCED SENSITIVE MEDICATED- benzocaine, benzalkonium chloride cream 
SCI International, Inc. DBA Continental Pharmaceuticals

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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Vagi-Cure Advanced Sensitive Medicated

Active ingredients

Benzocaine                     5%

Benzalkonium Chloride  .13%

Purpose

External Analgesic

External Antiseptic

Uses

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.

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

adult 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

Aloe Vera Gel, Carbomer, Cetyl Alcohol, De-ionized Water, Disodium EDTA, Fragrance, Glycerol Monostearate, Isopropyl Myristate, Isopropyl Palmitate, Lanolin Anhydrous, Methylparaben, Mineral Oil, Peg 100 Stearate, Propylene Glycol, Propylparaben, Vitamin E (Tocopheryl Acetate). 

PRINCIPAL DISPLAY PANEL 

Vagi-Cure

Anti-Itch Cream

Advance Sensitive Medicated Cream

NET WT 0.75oz (21g)

label of vagi-cure advance

VAGI-CURE ADVANCED SENSITIVE MEDICATED 
benzocaine, benzalkonium chloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76466-011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE5 g  in 100 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
WATER (UNII: 059QF0KO0R)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
LANOLIN (UNII: 7EV65EAW6H)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MINERAL OIL (UNII: T5L8T28FGP)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76466-011-0721 g in 1 TUBE; Type 0: Not a Combination Product06/30/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/30/2016
Labeler - SCI International, Inc. DBA Continental Pharmaceuticals (114220648)
Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
Establishment
NameAddressID/FEIBusiness Operations
Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(76466-011)

Revised: 2/2022
Document Id: d8c30919-0dee-4c4e-e053-2995a90a0dab
Set id: 624a948a-8db6-4834-aead-ed8dfbe97e03
Version: 2
Effective Time: 20220224
 
SCI International, Inc. DBA Continental Pharmaceuticals