Label: ASSURED FEMININE ANTI-ITCH- benzocaine resorcinol cream
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Contains inactivated NDC Code(s)
NDC Code(s): 33992-2014-1 - Packager: Greenbrier International
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated April 4, 2017
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- Active ingredients
- Purpose
- Uses
- Warnings
- Stop use and ask a doctor if
- Keep out of reach of children
- Directions
- Other information
- Inactive ingredients
- Package Label
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INGREDIENTS AND APPEARANCE
ASSURED FEMININE ANTI-ITCH
benzocaine resorcinol creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:33992-2014 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 5 g in 100 g RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK) RESORCINOL 2 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) MINERAL OIL (UNII: T5L8T28FGP) HYDROXYPROPYL BISSTEARYLDIMONIUM CHLORIDE (UNII: OVB1E9X12I) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:33992-2014-1 21 g in 1 TUBE; Type 0: Not a Combination Product 03/31/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 03/31/2017 Labeler - Greenbrier International (610322518) Establishment Name Address ID/FEI Business Operations FRONT PHARMACEUTICAL PLC 530897792 manufacture(33992-2014)