VAGI-CURE (MAXIMUM STRENGTH): Package Insert and Label Information

VAGI-CURE (MAXIMUM STRENGTH)- benzocaine and resorcinol cream
SCI International, Inc. DBA Continental Pharmaceuticals

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 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 – 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)

VAGI-CURE (MAXIMUM STRENGTH) benzocaine, resorcinol cream

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

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (BENZOCAINE) BENZOCAINE 200 mg in 1 g RESORCINOL (RESORCINOL) RESORCINOL 30 mg in 1 g

Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) CETYL ALCOHOL WATER EDETATE DISODIUM GLYCERYL MONOSTEARATE ISOPROPYL MYRISTATE ISOPROPYL PALMITATE METHYLPARABEN MINERAL OIL PEG-100 STEARATE PROPYLENE GLYCOL PROPYLPARABEN .ALPHA.-TOCOPHEROL ACETATE TROLAMINE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:76466-010-07 28 g in 1 TUBE None

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	Operations
NATURAL ESSENTIALS, INC.		947484713	MANUFACTURE (76466-010)

Revised: 01/2018 SCI International, Inc. DBA Continental Pharmaceuticals