Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 30c61c70-abe3-2950-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2016-05-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (5.6 g) Resorcinol (0.84 g)
Inactive Ingredients
Cetyl Alcohol Propylene Glycol Peg-100 Stearate Glyceryl Monostearate Peg-40 Hydrogenated Lanolin Isopropyl Palmitate Carbomer Homopolymer Type C Trolamine Methylparaben .alpha.-tocopherol Acetate Hydroxyethyl Cellulose (1500 Mpa.s At 1%) Xanthan Gum Maltodextrin Propylparaben Edetate Disodium Aloe Vera Leaf Mineral Oil Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-05-01

Description

Benzocaine 20% Resorcinol 3%

Purpose

External Analgesic External Analgesic


Medication Information

Indications and Usage

Temporarily relieves itching

Purpose

External Analgesic

External Analgesic

Description

Benzocaine 20% Resorcinol 3%

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

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.

Section 50567-7

When using this product avoid contact with the eyes

Section 50570-1

Do not apply over large areas of the body

Section 51945-4

Maximum Strength

Vagicaine

Medicated anti-itch cream

Net Wt 1 oz (28g)

CVS Health TM Maximum Strength Vagicaine Medicaided Anti-Itch Cream provides instant relief from painful, burning itch using the power of benzocaine and resorcinol combined with the soothing vitamin E plus aloe.

*This product is not manufactured or distributed by Combe Inc., owner of the registered trademark Vagisil TM maximum Strength Anti-Itch Cream

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02995

(c) 2016 CVS/pharmacy

CVS.com (R) 1-800-SHOP CVS V-31535

CVS (R) Quality

Money Back Guarantee

Warnings

For external use only

Directions
adults and children 12 years and older apply a fingertip amount (appriximately 1-inch strip) to the affected area not more than 3 to 4 times daily
children under 12 years ask a doctor

Other Information
  • store at 20º-25ºC (68º - 77ºF)
Active Ingredients

Benzocaine 20%

Resorcinol 3%

Inactive Ingredients

Water, Mineral Oil, Cetyl Alcohol, Propylene Glycol, PEG-100 Stearate and Glyceryl Monostearate, PEG-40 Hydrogenated Castor Oil, Isopropyl Palmitate, Carbomer, Triethanolamine, Methylparaben, Tocopheryl Acetate, Hydroxyethylcelluse, Xanthan Gum, Maltodextrin, Propylparaben, Disodium EDTA, Aloe Barbadensis (Alow Vera) Leaf Extract, Fragrance


Structured Label Content

Indications and Usage (34067-9)

Temporarily relieves itching

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

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.

Section 50567-7 (50567-7)

When using this product avoid contact with the eyes

Section 50570-1 (50570-1)

Do not apply over large areas of the body

Section 51945-4 (51945-4)

Maximum Strength

Vagicaine

Medicated anti-itch cream

Net Wt 1 oz (28g)

CVS Health TM Maximum Strength Vagicaine Medicaided Anti-Itch Cream provides instant relief from painful, burning itch using the power of benzocaine and resorcinol combined with the soothing vitamin E plus aloe.

*This product is not manufactured or distributed by Combe Inc., owner of the registered trademark Vagisil TM maximum Strength Anti-Itch Cream

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02995

(c) 2016 CVS/pharmacy

CVS.com (R) 1-800-SHOP CVS V-31535

CVS (R) Quality

Money Back Guarantee

Purpose

External Analgesic

External Analgesic

Warnings

For external use only

Directions
adults and children 12 years and older apply a fingertip amount (appriximately 1-inch strip) to the affected area not more than 3 to 4 times daily
children under 12 years ask a doctor

Other Information
  • store at 20º-25ºC (68º - 77ºF)
Active Ingredients

Benzocaine 20%

Resorcinol 3%

Inactive Ingredients

Water, Mineral Oil, Cetyl Alcohol, Propylene Glycol, PEG-100 Stearate and Glyceryl Monostearate, PEG-40 Hydrogenated Castor Oil, Isopropyl Palmitate, Carbomer, Triethanolamine, Methylparaben, Tocopheryl Acetate, Hydroxyethylcelluse, Xanthan Gum, Maltodextrin, Propylparaben, Disodium EDTA, Aloe Barbadensis (Alow Vera) Leaf Extract, Fragrance


Advanced Ingredient Data


Raw Label Data

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