Vagi-Cure Advanced Sensitive Medicated: Package Insert and Label Information

VAGI-CURE ADVANCED SENSITIVE MEDICATED- benzocaine and benzalkonium chloride 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.

Active ingredients

Benzocaine 5%

Benzalkonium Chloride .13%

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.

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

adult and children 2 years and older

apply a fingertip amount (approximately 1-inch strip) to affected area not more than 3 to 4 times daily.

children under 2 years

consult a doctor

Inactive 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 (Tocopheryl Acetate).

PRINCIPAL DISPLAY PANEL

Vagi-Cure

Anti-Itch Cream

Advance Sensitive Medicated Cream

NET WT 0.75oz (21g)

label of vagi-cure advance
(click image for full-size original)
VAGI-CURE ADVANCED SENSITIVE MEDICATED
benzocaine, benzalkonium chloride cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:76466-011
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOCAINE (BENZOCAINE) BENZOCAINE 5 g in 100 g
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 0.13 g in 100 g
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF
CARBOXYPOLYMETHYLENE
CETYL ALCOHOL
WATER
EDETATE DISODIUM
GLYCERYL MONOSTEARATE
ISOPROPYL MYRISTATE
ISOPROPYL PALMITATE
LANOLIN
METHYLPARABEN
MINERAL OIL
PEG-100 STEARATE
PROPYLENE GLYCOL
PROPYLPARABEN
.ALPHA.-TOCOPHEROL ACETATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76466-011-07 21 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 06/30/2016
Labeler — SCI International, Inc. DBA Continental Pharmaceuticals (114220648)
Registrant — Anicare Pharmaceuticals Pvt. Ltd (916837425)
Establishment
Name Address ID/FEI Operations
Anicare Pharmaceuticals Pvt. Ltd 916837425 manufacture (76466-011)

Revised: 07/2016 SCI International, Inc. DBA Continental Pharmaceuticals

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