VAGI-CURE (MAXIMUM STRENGTH)- benzocaine, resorcinol cream

VAGI-CURE (MAXIMUM STRENGTH) by

Drug Labeling and Warnings

VAGI-CURE (MAXIMUM 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]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Benzocaine 20%

Resorcinol 3%

Purpose

External Analgesic

External Antiseptic

Uses

• Temporarily relieves itching

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. Also, 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 out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

apply a fingertip amount adults and children (approximately 1-inch strip) 12 years and older to affected area not more than 3 to 4 times daily children under 12 years consult a doctor

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL – TUBE 1 oz (28g) LABEL

FAST RELIEF from everyday itch!

~Recommended By Women~

Vagi-Cure

Anti-Itch Cream

Maximum Strength Medicated Cream

NET WT 1oz (28g)

INGREDIENTS AND APPEARANCE

VAGI-CURE (MAXIMUM STRENGTH) 
benzocaine, resorcinol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76466-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	200 mg  in 1 g
RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK)	RESORCINOL	30 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)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
PEG-100 STEARATE (UNII: YD01N1999R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76466-010-07	28 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(76466-010)