Label: VAGI CARE- benzocaine, benzalkonium chloride cream
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Contains inactivated NDC Code(s)
NDC Code(s): 29500-2264-1 - Packager: Personal Care Products
- 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 July 25, 2020
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Vagi Care
For external use only.
Avoid contact with eyes. In case of eye contact, flush with plenty of water. If irritation persist, seek medical advice.
Stop use and ask a doctor if conditin worsens, or if symptoms persist for more than 7 days or clear up and reoccur within a few days.
Do not apply over large areas of skin.
- ACTIVE INGREDIENT
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WARNINGS
warnings
For external use only.
Avoid contact with eyes. In case of eye contact flush with plenty of water. If irritation persist, seek medical advice.
Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days, or clear up and reoccur within a few days.
Do not apply over large areas of skin.
- DOSAGE & ADMINISTRATION
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- PURPOSE
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
VAGI CARE
benzocaine, benzalkonium chloride creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:29500-2264 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 1.05 g in 21 g BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.003 g in 21 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) CETYL ALCOHOL (UNII: 936JST6JCN) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCOL STEARATE (UNII: 0324G66D0E) HYDROXYPROPYL BISSTEARYLDIMONIUM CHLORIDE (UNII: OVB1E9X12I) METHYLPARABEN (UNII: A2I8C7HI9T) MINERAL OIL (UNII: T5L8T28FGP) PEG-100 STEARATE (UNII: YD01N1999R) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) Product Characteristics Color Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:29500-2264-1 21 g in 1 TUBE; Type 0: Not a Combination Product 03/01/2020 
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/01/2013 Labeler - Personal Care Products (966155082) Registrant - anicare pharmaceuticals pvt.ltd (916837425) Establishment Name Address ID/FEI Business Operations anicare pharmaceuticals pvt.ltd 916837425 manufacture(29500-2264)
