Vagicaine Maximum Strength Anti-Itch Cream: Package Insert and Label Information

VAGICAINE MAXIMUM STRENGTH ANTI-ITCH CREAM- benzocaine and resorcinol cream
CVS Pharmacy

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.

Active Ingredients

Benzocaine 20%

Resorcinol 3%

Purpose

External Analgesic

External Analgesic

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

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

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Principal Display Panel
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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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOCAINE (BENZOCAINE) BENZOCAINE 5.6 g in 28 g
RESORCINOL (RESORCINOL) RESORCINOL 0.84 g in 28 g
Inactive Ingredients
Ingredient Name Strength
CETYL ALCOHOL
PROPYLENE GLYCOL
PEG-100 STEARATE
GLYCERYL MONOSTEARATE
PEG-40 HYDROGENATED LANOLIN
ISOPROPYL PALMITATE
CARBOMER HOMOPOLYMER TYPE C
TROLAMINE
METHYLPARABEN
.ALPHA.-TOCOPHEROL ACETATE
HYDROXYETHYL CELLULOSE (1500 MPA.S AT 1%)
XANTHAN GUM
MALTODEXTRIN
PROPYLPARABEN
EDETATE DISODIUM
ALOE VERA LEAF
MINERAL OIL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59779-588-01 1 TUBE in 1 CARTON contains a TUBE
1 28 g in 1 TUBE This package is contained within the CARTON (59779-588-01)
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 Operations
BioZone Laboratories, Inc. 555564293 manufacture (59779-588)
Establishment
Name Address ID/FEI Operations
BioZone Laboratories, Inc 962455320 manufacture (59779-588)

Revised: 04/2016 CVS Pharmacy

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