NDC | 76466-010-07 |
Set ID | b4455a7e-e995-482e-b29f-2ec1082dbd91 |
Category | HUMAN OTC DRUG LABEL |
Packager | SCI International, Inc. DBA Continental Pharmaceuticals |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART348 |
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
- Uses
-
Warnings
For external use only
Avoid contact with eyes
- Directions
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
VAGI-CURE (MAXIMUM STRENGTH)
benzocaine, resorcinol creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76466-010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 200 mg in 1 g RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK) RESORCINOL 30 mg in 1 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) CETYL ALCOHOL (UNII: 936JST6JCN) WATER (UNII: 059QF0KO0R) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) METHYLPARABEN (UNII: A2I8C7HI9T) MINERAL OIL (UNII: T5L8T28FGP) PEG-100 STEARATE (UNII: YD01N1999R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76466-010-07 28 g in 1 TUBE; Type 0: Not a Combination Product 01/01/2011 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 Business Operations NATURAL ESSENTIALS, INC. 947484713 MANUFACTURE(76466-010)