Vagicaine: Package Insert and Label Information

VAGICAINE — benzocaine and resorcinol cream
Personal Care Products, Inc.

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.

Benzocaine 20%
Resorcinol 3%

Purpose

External analgesic

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)

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 than7 days or clear up and occur again within a few days

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

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

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.

PCVagicaine Label
(click image for full-size original)

PCVagicaine Label
VAGICAINE
benzocaine, resorcinol cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:29500-7820
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOCAINE (BENZOCAINE) BENZOCAINE 5.67 g in 28 g
RESORCINOL (RESORCINOL) RESORCINOL 0.85 g in 28 g
Inactive Ingredients
Ingredient Name Strength
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
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:29500-7820-1 28 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 02/28/2014
Labeler — Personal Care Products, Inc. (966155082)

Revised: 05/2014 Personal Care Products, Inc.

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