VAGISIL ANTI-ITCH MEDICATED CREME MAXIMUM STRENGTH- benzocaine and resorcinol cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5), RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK)

Available from:

Combe Incorporated

INN (International Name):

BENZOCAINE

Composition:

BENZOCAINE 50 mg in 1 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

External analgesic External analgesic temporarily relieves itching condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days

Authorization status:

OTC monograph not final

Summary of Product characteristics

VAGISIL ANTI-ITCH MEDICATED CREME MAXIMUM STRENGTH- BENZOCAINE AND
RESORCINOL CREAM
COMBE INCORPORATED
_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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VAGISIL ANTI-ITCH MEDICATED CREME
VAGISIL MAXIMUM STRENGTH ANTI-ITCH CREME
DRUG FACTS
ACTIVE INGREDIENT
Benzocaine 20%
PURPOS E
External analgesic
ACTIVE INGREDIENT
Resorcinol 3%
PURPOS E
External analgesic
US E
temporarily relieves itching
WARNINGS
FOR EXTERNAL USE ONLY
ALLERGY ALLERT
Do not use this product if you have a history of allergy to local
anesthetics such as procaine, butacaine,
benzocaine or other –caine anesthetics.
AVOID CONTACT WITH EYES
in case of contact rinse thoroughly and immediately with water.
STOP USE AND ASK DOCTOR IF
condition worsens, or if symptoms persist for more than 7 days, or
clear up and occur again within a
few days
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
right away.
DIRECTIONS
adults and children 12
years and older
Apply a fingertip amount (approximately 1-inch
strip) to affected area not more than 3 to 4 times
daily. Clean nozzle of tube by wiping
thoroughly before replacing cap. Keep cap
tightly closed between uses.
children under 12 years
consult a doctor
OTHER INFORMATION:
questions? call 1-800-431-2610, 9 am to 5 pm est
INACTIVE INGREDIENTS
Water, Mineral Oil, Cetyl Alcohol, Propylene Glycol, Glyceryl
Stearate, PEG-100 Stearate, Isopropyl
Palmitate, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate, Retinyl
Palmitate, Zea Mays (Corn) Oil,
Cholecalciferol, Lanolin Alcohol, Fragrance, Methylparaben, Carbomer,
Isopropyl Myristate,
Isopropyl Stearate, Sodium Sulfite, Triethanolamine, Trisodium HEDTA,
Maltodextrin
PRINCIPAL DISPLAY PANEL
VAGIS IL
MAXIMUM STRENGTH
ANTI-ITCH CREME
NET WT. 1 OZ. (28 G)
®
VAGISIL ANTI-ITCH MEDICATED CREME MAXIMUM STRENGTH
benzocaine and resorcinol cream
PRODUCT INFORMATION