Clotrimazole: Package Insert and Label Information

CLOTRIMAZOLE- clotrimazole cream
Walgreens

Drug Facts

Active ingredients

Clotrimazole, USP 1% (50 mg in each applicatorful)

Clotrimazole USP, 1% (external cream)

Purpose

Vaginal antifungal

Vaginal antifungal

Uses

  • treats vaginal yeast infections
  • relieves external itching and irritation due to a vaginal yeast infection

Warnings

For vaginal use only

Do not use

if you have never had a vaginal yeast infection diagnosed by a doctor

Ask a doctor before use if you have

  • vaginal itching and discomfort for the first time
  • lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have a more serious condition.
  • vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant, or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system.
  • been exposed to the human immunodeficiency virus (HIV) that causes AIDS

When using this product

  • do not use tampons, douches, spermicides, or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted diseases (STDs).
  • do not have vaginal intercourse
  • mild increase in vaginal burning, itching or irritation may occur
  • if you do not get complete relief, ask a doctor before using another product

Stop use and ask a doctor if

  • symptoms do not get better in 3 days
  • symptoms last more than 7 days.
  • you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or a foul-smelling vaginal discharge

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

  • before using this product, read the enclosed educational brochure for complete directions and information
  • adults and children 12 years of age and over:
    • vaginal cream: insert one applicatorful of cream into the vagina at bedtime for 7 days in a row. Wash applicator after each use.
    • external cream: use the same tube of cream if you have itching and irritation on the skin outside the vagina. Squeeze a small amount of cream onto your fingertip. Apply to itchy, irritated skin outside the vagina. Use 2 times daily for up to 7 days as needed.
  • children under 12 years of age: ask a doctor

Other information

  • to open tube: unscrew cap, lift tab, and pull to remove foil seal prior to use
  • do not use if foil seal on tube opening is broken or missing
  • do not purchase if carton is open
  • store at room temperature 20º to 25ºC (68º to 77ºF)
  • before using any medication, read all label directions. Keep carton, it contains important information.

Inactive ingredients

benzyl alcohol, cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sodium phosphate monobasic, sorbitan monostearate

Questions?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal display panel

Clotrimazole 7

VAGINAL CREAM, USP 1%

VAGINAL ANTIFUNGAL | 7-DAY TREATMENT

  • Clotrimazolevaginal cream can kill the yeast that may cause vaginal infection
  • Cures most vaginal yeast infections
  • Educational pamphlet enclosed

ONE 1.59 OZ (45g) TUBE OF VAGINAL CREAM (1%) & 1 REUSABLE APPLICATOR (7-DAY THERAPY)

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 6005

Package label

Clotrimazole, USP 1% (50 mg in each applicatorful), Clotrimazole, USP 1% (external cream)
(click image for full-size original)

WALGREENS Vaginal Cream with Reusable Applicator

CLOTRIMAZOLE
clotrimazole cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0220
Route of Administration VAGINAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLOTRIMAZOLE (CLOTRIMAZOLE) CLOTRIMAZOLE 10 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL
CETOSTEARYL ALCOHOL
CETYL ESTERS WAX
OCTYLDODECANOL
POLYSORBATE 60
WATER
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
SORBITAN MONOSTEARATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-0220-63 1 TUBE in 1 CARTON contains a TUBE
1 45 g in 1 TUBE This package is contained within the CARTON (0363-0220-63)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074165 09/01/1998
Labeler — Walgreens (008965063)

Revised: 10/2022 Walgreens

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2022. All Rights Reserved.