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)

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

(click image for full-size original)

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