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)

PRINCIPAL DISPLAY PANEL – TUBE 1 oz (28g) LABEL
(click image for full-size original)
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

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