Label: VAGI-CURE (REGULAR STRENGTH)- benzocaine, benzalkonium chloride cream
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Contains inactivated NDC Code(s)
NDC Code(s): 76466-075-07 - Packager: SCI International, Inc. DBA Continental Pharmaceuticals
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated January 24, 2018
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- PURPOSE
- INDICATIONS & USAGE
- INACTIVE INGREDIENT
- Directions:
- Active ingredients:
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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.
- STORAGE AND HANDLING
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
VAGI-CURE (REGULAR STRENGTH)
benzocaine, benzalkonium chloride creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76466-075 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 50 mg in 1 g BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE .13 mg in 1 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:76466-075-07 21 g in 1 TUBE; Type 0: Not a Combination Product 01/01/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/01/2011 Labeler - SCI International, Inc. DBA Continental Pharmaceuticals (114220648) Establishment Name Address ID/FEI Business Operations NATURAL ESSENTIALS, INC. 947484713 MANUFACTURE(76466-075)