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

VAGISIL Anti-Itch Medicated Creme Maximum Strength by

Drug Labeling and Warnings

VAGISIL Anti-Itch Medicated Creme Maximum Strength by is a Otc medication manufactured, distributed, or labeled by Combe Incorporated. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

VAGISIL Maximum Strength Anti-Itch Creme

Drug Facts

Active ingredient

Benzocaine 20%

Purpose

External analgesic

Active ingredient

Resorcinol 3%

Purpose

External analgesic

Use

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 12years 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

Vagisil®
Maximum Strength
Anti-Itch Creme

Net Wt. 1 oz. (28 g)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11509-4402
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	200 mg  in 1 g
RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK)	RESORCINOL	30 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MINERAL OIL (UNII: T5L8T28FGP)
CETYL ALCOHOL (UNII: 936JST6JCN)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
POLYOXYL 100 STEARATE (UNII: YD01N1999R)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
CORN OIL (UNII: 8470G57WFM)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)
METHYLPARABEN (UNII: A2I8C7HI9T)
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ISOPROPYL STEARATE (UNII: 43253ZW1MZ)
SODIUM SULFITE (UNII: VTK01UQK3G)
TROLAMINE (UNII: 9O3K93S3TK)
TRISODIUM HEDTA (UNII: K3E0U7O8KI)
MALTODEXTRIN (UNII: 7CVR7L4A2D)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11509-4402-1	1 in 1 CARTON	08/01/1974
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	08/01/1974

Labeler - Combe Incorporated (002406502)