VAGICAINE MAXIMUM STRENGTH ANTI-ITCH CREAM- benzocaine, resorcinol cream

Vagicaine Maximum Strength Anti-Itch Cream by

Drug Labeling and Warnings

Vagicaine Maximum Strength Anti-Itch Cream by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, BioZone Laboratories, Inc., BioZone Laboratories, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Benzocaine 20%

Resorcinol 3%

Purpose

External Analgesic

External Analgesic

INDICATIONS & USAGE

Temporarily relieves itching

Warnings

For external use only

When using this product avoid contact with the 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

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

Other Information

• store at 20º-25ºC (68º - 77ºF)

Inactive Ingredients

Water, Mineral Oil, Cetyl Alcohol, Propylene Glycol, PEG-100 Stearate and Glyceryl Monostearate, PEG-40 Hydrogenated Castor Oil, Isopropyl Palmitate, Carbomer, Triethanolamine, Methylparaben, Tocopheryl Acetate, Hydroxyethylcelluse, Xanthan Gum, Maltodextrin, Propylparaben, Disodium EDTA, Aloe Barbadensis (Alow Vera) Leaf Extract, Fragrance

PRINCIPAL DISPLAY PANEL

Maximum Strength

Vagicaine

Medicated anti-itch cream

Net Wt 1 oz (28g)

CVS Health TM Maximum Strength Vagicaine Medicaided Anti-Itch Cream provides instant relief from painful, burning itch using the power of benzocaine and resorcinol combined with the soothing vitamin E plus aloe.

*This product is not manufactured or distributed by Combe Inc., owner of the registered trademark Vagisil TM maximum Strength Anti-Itch Cream

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02995

(c) 2016 CVS/pharmacy

CVS.com (R) 1-800-SHOP CVS V-31535

CVS (R) Quality

Money Back Guarantee

INGREDIENTS AND APPEARANCE

VAGICAINE MAXIMUM STRENGTH ANTI-ITCH CREAM 
benzocaine, resorcinol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-588
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	5.6 g  in 28 g
RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK)	RESORCINOL	0.84 g  in 28 g

Inactive Ingredients
Ingredient Name	Strength
CETYL ALCOHOL (UNII: 936JST6JCN)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-40 HYDROGENATED LANOLIN (UNII: 959P5CXE48)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
TROLAMINE (UNII: 9O3K93S3TK)
METHYLPARABEN (UNII: A2I8C7HI9T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HYDROXYETHYL CELLULOSE (1500 MPA.S AT 1%) (UNII: L605B5892V)
XANTHAN GUM (UNII: TTV12P4NEE)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MINERAL OIL (UNII: T5L8T28FGP)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-588-01	1 in 1 CARTON	05/01/2016
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/01/2016

Labeler - CVS Pharmacy (062312574)

Establishment
Name	Address	ID/FEI	Business Operations
BioZone Laboratories, Inc.		555564293	manufacture(59779-588)

Establishment
Name	Address	ID/FEI	Business Operations
BioZone Laboratories, Inc		962455320	manufacture(59779-588)