VAGI-CURE (REGULAR STRENGTH)- 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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Directions:

Apply liberally to affected area. If needed may be repeated three top four times daily. Children under (2) two years of age: Consult a physician.

Active 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 (tocopherol)

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 use if you have an unusual or abnormal vaginal discharge except under the supervision of a physician. Do not apply over large areas of the body.

Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Store at 15 to 30C (49 to 85F)

Manufactured for:
Continental Pharmaceutical Inc.
5904 Enterprise Court
Frederick MD 21703
Web: scimedic.com
03-0096

Principal Display Panel – Tube Label

FAST REFIEF from everyday itch!

~Recommended By Women~

Vagi-cure

Anti-Itch Cream

Advanced Sensitive Medicated Cream

Principal Display Panel – Tube Label
VAGI-CURE (REGULAR STRENGTH) 
benzocaine, benzalkonium chloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76466-075
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE50 mg  in 1 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE.13 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
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:76466-075-0721 g in 1 TUBE; Type 0: Not a Combination Product01/01/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/01/2011
Labeler - SCI International, Inc. DBA Continental Pharmaceuticals (114220648)
Establishment
NameAddressID/FEIBusiness Operations
NATURAL ESSENTIALS, INC.947484713MANUFACTURE(76466-075)

Revised: 1/2018
Document Id: caa8ffd8-895a-46f9-8e89-2b408b336a9f
Set id: 2f685c77-86d2-4558-80e0-550846598e76
Version: 2
Effective Time: 20180124
 
SCI International, Inc. DBA Continental Pharmaceuticals