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

Purpose

External Analgesic External Analgesic

Description

Benzocaine 20% Resorcinol 3%


Medication Information

Warnings

For external use only

Indications and Usage

Temporarily relieves itching

Purpose

External Analgesic

External Analgesic

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)
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

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

Active Ingredients

Benzocaine 20%

Resorcinol 3%


Structured Label Content

Warnings

For external use only

Indications and Usage (34067-9)

Temporarily relieves itching

Purpose

External Analgesic

External Analgesic

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)
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

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

Active Ingredients

Benzocaine 20%

Resorcinol 3%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)