Vagi Care: Package Insert and Label Information

VAGI CARE- benzocaine and 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.

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)

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VAGI CARE
benzocaine, benzalkonium chloride cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:29500-2264
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOCAINE (BENZOCAINE) BENZOCAINE 1.05 g in 21 g
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 0.003 g in 21 g
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF
CETYL ALCOHOL
DIAZOLIDINYL UREA
DIMETHICONE
GLYCOL STEARATE
HYDROXYPROPYL BISSTEARYLDIMONIUM CHLORIDE
METHYLPARABEN
MINERAL OIL
PEG-100 STEARATE
POLYETHYLENE GLYCOL 400
PROPYLPARABEN
WATER
.ALPHA.-TOCOPHEROL
Product Characteristics
Color Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:29500-2264-1 21 g in 1 TUBE None
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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 Operations
anicare pharmaceuticals pvt.ltd 916837425 manufacture (29500-2264)

Revised: 07/2020 Personal Care Products

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