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

VAGI-CURE (REGULAR STRENGTH)- 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.

Directions:

Apply liberally to affected area. If needed may be repeated three top four times daily. Children under (2) two years of age: Consult a physician.

Active 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 (tocopherol)

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 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 this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Store at 15 to 30C (49 to 85F)

Manufactured for:
Continental Pharmaceutical Inc.
5904 Enterprise Court
Frederick MD 21703
Web: scimedic.com
03-0096

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Principal Display Panel – Tube Label
(click image for full-size original)
VAGI-CURE (REGULAR STRENGTH)
benzocaine, benzalkonium chloride cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:76466-075
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOCAINE (BENZOCAINE) BENZOCAINE 50 mg in 1 g
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE .13 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
LANOLIN
METHYLPARABEN
MINERAL OIL
PEG-100 STEARATE
PROPYLENE GLYCOL
PROPYLPARABEN
.ALPHA.-TOCOPHEROL ACETATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76466-075-07 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 01/01/2011
Labeler — SCI International, Inc. DBA Continental Pharmaceuticals (114220648)
Establishment
Name Address ID/FEI Operations
NATURAL ESSENTIALS, INC. 947484713 MANUFACTURE (76466-075)

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

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