VAGI CARE- benzocaine, benzalkonium chloride cream 
Personal Care Products

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.

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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

Benzocaine 5.0%

Benzalkonium Chloride 0.13%

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.

Directions adults and children 2 years and older-Apply fingertip amount (approximately 1-inch strip) to affected area not more than 3 to 4 times daily

children under 2 years-consult a doctor

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center.

Uses temporarily relieves itching

Purpose External Analgesic

Aloe Barbadensis (aloe vera) gel, cetryl alcohol, diazolidinyl urea, dimethicone, glycol stearate, hydroxypropyl bisstearyldimonium chloride, methyl paraben, mineral oil, PEG 100 stearate, PEG 400, propyl paraben, prified water, tocopheryl acetate (vitamin e)

image description

VAGI CARE 
benzocaine, benzalkonium chloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29500-2264
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE1.05 g  in 21 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.003 g  in 21 g
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:29500-2264-121 g in 1 TUBE; Type 0: Not a Combination Product03/01/2020
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/01/2013
Labeler - Personal Care Products (966155082)
Registrant - anicare pharmaceuticals pvt.ltd (916837425)
Establishment
NameAddressID/FEIBusiness Operations
anicare pharmaceuticals pvt.ltd916837425manufacture(29500-2264)

Revised: 7/2020
Document Id: ab466948-72ff-f67d-e053-2995a90a6a43
Set id: 4ff50f17-7679-4a7a-994a-bda6cd23cb90
Version: 3
Effective Time: 20200725
 
Personal Care Products