SPL v5
SPL
SPL Set ID f2cf120a-0a4a-45db-b392-d3d47a47ba70
Route
TOPICAL
Published
Effective Date 2014-04-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (5.67 g) Resorcinol (0.85 g)
Inactive Ingredients
Aloe Vera Leaf Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Cetyl Alcohol Cholecalciferol Glyceryl Monostearate Isopropyl Myristate Isopropyl Palmitate Isopropyl Stearate Lanolin Methylparaben Mineral Oil Peg-100 Stearate Propylene Glycol Water Vitamin A Palmitate Sodium Hydroxide Sodium Sulfite .alpha.-tocopherol Acetate Trisodium Hedta

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-02-28

Description

Benzocaine  20% Resorcinol  3%

Purpose

External analgesic


Medication Information

Purpose

External analgesic

Description

Benzocaine  20% Resorcinol  3%

Use

temporarily relieves itching

Warnings

For external use only

Other Information

store at 20° -25° C (68° -77° F)

Inactive Ingredients

aloe barbadensis leaf extract, carbomer, cetyl alcohol, cholecalciferol, glyceryl monostearate, isopropyl myristate, isopropyl palmitate, isopropyl sterate, lanolin, methylparaben, mineral iol, PEG-100 stearate, propylene glycol, purified water, retinyl palmitate, sodium hydroxide, sodium sulfite, tocopheryl acetate, trisodium HEDTA



Questions Or Comments?

1-888-287-1915

Do Not Apply Directions

Do not apply over large area of the body.

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

children under 12 years                                         ask a doctor

Vagicaine Product Label

equate™

Compare to Vagisil Maxium Strength Active Ingredients ®

Maxium Strength

Vagicaine



Anti-Itch Cream



Bennzocaine 20%, Resorcinol 3%

Instant, Long-Lasting Relief from Intense Itch

Pain relieving cream



Soothes with Vitamins E, A and D plus Aloe

NET T 1 OZ(28 g)

Satisfaction guaranteed - Or we'll replace it or give you your money back. For questions or comments or to report an undesired reaction or side effect, please call 1-888-287-1915

distributed by:

Wal-Mart Stores, Inc.

Bentonville, AR 7276

*This product is not manufactured or distributed by Combe Incorporated, owner of the registered trade mark Vagisil® Maxium Strength.







When Using This Product

avoid contact with the eyes

Stop Use and Ask A Doctor If

condition worsens, or if symptoms persist for more than7 days or clear up and occur again within a few days

Drug Facts Active Ingredients

Benzocaine  20%

Resorcinol  3%

Keep Out of Reach of Children

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1212)


Structured Label Content

Use

temporarily relieves itching

Purpose

External analgesic

Warnings

For external use only

Other Information

store at 20° -25° C (68° -77° F)

Inactive Ingredients

aloe barbadensis leaf extract, carbomer, cetyl alcohol, cholecalciferol, glyceryl monostearate, isopropyl myristate, isopropyl palmitate, isopropyl sterate, lanolin, methylparaben, mineral iol, PEG-100 stearate, propylene glycol, purified water, retinyl palmitate, sodium hydroxide, sodium sulfite, tocopheryl acetate, trisodium HEDTA



Questions Or Comments? (Questions or comments?)

1-888-287-1915

Do Not Apply Directions (Do not apply Directions)

Do not apply over large area of the body.

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

children under 12 years                                         ask a doctor

Vagicaine Product Label

equate™

Compare to Vagisil Maxium Strength Active Ingredients ®

Maxium Strength

Vagicaine



Anti-Itch Cream



Bennzocaine 20%, Resorcinol 3%

Instant, Long-Lasting Relief from Intense Itch

Pain relieving cream



Soothes with Vitamins E, A and D plus Aloe

NET T 1 OZ(28 g)

Satisfaction guaranteed - Or we'll replace it or give you your money back. For questions or comments or to report an undesired reaction or side effect, please call 1-888-287-1915

distributed by:

Wal-Mart Stores, Inc.

Bentonville, AR 7276

*This product is not manufactured or distributed by Combe Incorporated, owner of the registered trade mark Vagisil® Maxium Strength.







When Using This Product (When using this product)

avoid contact with the eyes

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

condition worsens, or if symptoms persist for more than7 days or clear up and occur again within a few days

Drug Facts Active Ingredients (Drug Facts Active ingredients)

Benzocaine  20%

Resorcinol  3%

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1212)


Advanced Ingredient Data


Raw Label Data

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