Walgreens Clotrimazole 3: Package Insert and Label Information

WALGREENS CLOTRIMAZOLE 3- clotrimazole cream
Walgreen Company

Drug Facts

Active ingredients Purpose
Clotrimazole USP 2% (100 mg in each applicatorful) Vaginal antifungal
Clotrimazole USP 2% (external cream) 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 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 3 days in a row. Throw applicator away after 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: unscrew cap, use pointed end on cap to puncture seal
  • do not use if carton is opened
  • safety sealed: the tube opening should be sealed. If the seal has been punctured or is not visible, do not use the product.
  • store between 20° to 25°C (68° to 77°F)
  • see flap of carton or crimp of tube for lot number and expiration date

Inactive ingredients

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

Questions or comments?

call 1-866-923-4914

DISTRIBUTED BY: WALGREEN CO. 200 WILMOT RD., DEERFIELD, IL 60015

PRINCIPAL DISPLAY PANEL — 21 g Tube Carton

Walgreens

Compare to Gyne-Lotrimin 3®
active ingredient††

NDC 0363-2062-01

Clotrimazole 3 CLOTRIMAZOLE VAGINAL CREAM USP (2%)

VAGINAL ANTIFUNGAL | 3-DAY TREATMENT

  • Cures most vaginal yeast infections
  • Educational Brochure Enclosed

NET WT 0.74 OZ (21 g) TUBE &
3 DISPOSABLE APPLICATORS

PRINCIPAL DISPLAY PANEL -- 21 g Tube Carton
(click image for full-size original)
WALGREENS CLOTRIMAZOLE 3
clotrimazole cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-2062
Route of Administration VAGINAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Clotrimazole (Clotrimazole) Clotrimazole 2 g in 100 g
Inactive Ingredients
Ingredient Name Strength
benzyl alcohol
cetostearyl alcohol
cetyl esters wax
octyldodecanol
polysorbate 60
water
sorbitan monostearate
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-2062-01 1 TUBE, WITH APPLICATOR in 1 CARTON contains a TUBE, WITH APPLICATOR
1 21 g in 1 TUBE, WITH APPLICATOR This package is contained within the CARTON (0363-2062-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021143 04/12/2000
Labeler — Walgreen Company (008965063)
Registrant — Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
Name Address ID/FEI Operations
Taro Pharmaceuticals Inc. 206263295 MANUFACTURE (0363-2062)

Revised: 02/2018 Walgreen Company

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.