BENZAL VAGISIL CREME REGULAR 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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Benzal Vagisil Crème Regular Strength

Drug Facts

Active ingredient

Benzocaine 5%

Purpose

External analgesic

Active ingredient

Resorcinol 2%

Purpose

External analgesic

Use

temporarily relieves itching

Warnings

For external use only

Avoid contact with eyes

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

Do not apply over large areas of the body

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
children under 12 years	consult a doctor

Inactive ingredients

Water, Cetyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Mineral Oil, 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

benzal®
Regular Strength
Concentración normal

BENZAL VAGISIL CREME REGULAR STRENGTH
benzocaine and resorcinol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11509-6940
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	50 mg in 1 g
RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK)	RESORCINOL	20 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
POLYOXYL 100 STEARATE (UNII: YD01N1999R)
MINERAL OIL (UNII: T5L8T28FGP)
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11509-6940-1	1 in 1 CARTON	09/01/2015	09/02/2015
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part348	09/01/2015	09/02/2015

Labeler - Combe Incorporated (002406502)

Revised: 5/2018

Document Id: d265809f-4233-4d0b-bab5-2dddcd8a3c90

Set id: afd44d52-8f07-4f98-b4af-2997867a37b4

Version: 3

Effective Time: 20180504

Combe Incorporated