VAGI-CURE (REGULAR STRENGTH)- benzocaine, benzalkonium chloride cream

VAGI-CURE (REGULAR STRENGTH) by

Drug Labeling and Warnings

VAGI-CURE (REGULAR STRENGTH) by is a Otc medication manufactured, distributed, or labeled by SCI International, Inc. DBA Continental Pharmaceuticals, NATURAL ESSENTIALS, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

INDICATIONS & USAGE

INACTIVE INGREDIENT

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.

STORAGE AND HANDLING

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

Principal Display Panel – Tube Label

FAST REFIEF from everyday itch!

~Recommended By Women~

Vagi-cure

Anti-Itch Cream

Advanced Sensitive Medicated Cream

INGREDIENTS AND APPEARANCE

VAGI-CURE (REGULAR STRENGTH) 
benzocaine, benzalkonium chloride cream

Product 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)