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NDC 41250-0142-64 Vagicaine 20; 3 g/100g; g/100g Details

Vagicaine 20; 3 g/100g; g/100g

Vagicaine is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Meijer Distribution Inc. The primary component is BENZOCAINE; RESORCINOL.

Product Information

NDC	41250-0142
Product ID	41250-142_fea9d886-0541-4c24-93cc-fd7b02bfd5e7
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Vagicaine
Proprietary Name Suffix	Maximum Strength
Non-Proprietary Name	Benzocaine, Resorcinol
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	20; 3
Active Ingredient Units	g/100g; g/100g
Substance Name	BENZOCAINE; RESORCINOL
Labeler Name	Meijer Distribution Inc
Pharmaceutical Class	Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 41250-0142-64 (41250014264)

Pricing Information	N/A
NDC Package Code	41250-142-64
Billing NDC	41250014264
Package	1 TUBE in 1 CARTON (41250-142-64) / 28 g in 1 TUBE
Marketing Start Date	2009-05-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 56ffc40a-d688-4dd0-9eae-5435203d276e Details

Active ingredients

Benzocaine 20%

Resorcinol 3%

Purpose

External analgesic

Use

temporarily relieves itching

Warnings

For external use only

When using this product

avoid contact with the eyes

Stop use and ask a 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 (1-800-222-1222).

Directions

adults and children 12 years and older	apply a fingertip amount (approximately 1-inch strip) to the 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	ask a doctor

Other information

store at 20-25°C (68-77°F)

Inactive ingredients

aloe barbadensis leaf juice, carbomer homopolymer type C, cetyl alcohol, cholecalciferol, corn (zea mays) oil, fragrance, glyceryl monostearate, isopropyl myristate, isopropyl palmitate, isopropyl stearate, lanolin alcohol, methylparaben, mineral oil, PEG-100 stearate, propylene glycol, purified water, retinyl palmitate, sodium sulfite anhydrous, tocopheryl acetate, trisodium HEDTA, trolamine

Questions or comments?

1-800-719-9260

Principal Display Panel

MAXIMUM STRENGTH

vagicaine cream

GYNECOLOGIST AND CLINICALLY TESTED

Instant Long-Lasting Relief from Intense Itch

Fast Acting – Relieves Painful Itching, Burning & Irritation on Contact

Soothes with Viatmins E, A, & D + Aloe | Specifically Designed for the Vaginal Area

Compare to Vagisil® active ingredients

MAXIMUM STRENGTH

vagicaine cream

Pain Relieving Anti-Itch Cream

NET WT. 1 OZ (28 g)

Instant Relief

INGREDIENTS AND APPEARANCE

VAGICAINE MAXIMUM STRENGTH

benzocaine, resorcinol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41250-142
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	20 g in 100 g
RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK)	RESORCINOL	3 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
CETYL ALCOHOL (UNII: 936JST6JCN)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
CORN OIL (UNII: 8470G57WFM)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
ISOPROPYL STEARATE (UNII: 43253ZW1MZ)
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
PEG-100 STEARATE (UNII: YD01N1999R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
SODIUM SULFITE (UNII: VTK01UQK3G)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRISODIUM HEDTA (UNII: K3E0U7O8KI)
TROLAMINE (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:41250-142-64	1 in 1 CARTON	05/15/2009
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	05/15/2009

Labeler - Meijer Distribution Inc (006959555)

Revised: 2/2019

Document Id: fea9d886-0541-4c24-93cc-fd7b02bfd5e7

Set id: 56ffc40a-d688-4dd0-9eae-5435203d276e

Version: 5

Effective Time: 20190228