CLOTRIMAZOLE- clotrimazole cream 
H2-Pharma, LLC

----------

Clotrimazole

Drug Facts

Active ingredientsPurpose
Clotrimazole USP, 1% (50 mg in each applicatorful)Vaginal antifungal
Clotrimazole USP, 1% (external cream)Vaginal antifungal

Uses

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

Other 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

Distributed by: H2-Pharma, LLC
Montgomery, AL 36117
www.h2-pharma.com

PRINCIPAL DISPLAY PANEL - 45 g Tube Carton

NDC 61269-220-63

Clotrimazole
Vaginal Cream, USP 1%

Vaginal Antifungal
(with 1 Reusable Applicator)

Cures most vaginal yeast infections
7-day therapy / 7-day treatment
Educational pamphlet enclosed

Net wt. 1.59 oz (45 g) tube

7 day vaginal cream with 1 reusable applicator

H2 pharma

Principal Display Panel - 45 g Tube Carton
CLOTRIMAZOLE 
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61269-220
Route of AdministrationVAGINAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETYL ESTERS WAX (UNII: D072FFP9GU)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
WATER (UNII: 059QF0KO0R)  
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61269-220-411 in 1 CARTON06/29/2021
145 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
2NDC:61269-220-631 in 1 CARTON06/29/2021
245 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07416506/29/2021
Labeler - H2-Pharma, LLC (028473634)

Revised: 6/2021
Document Id: cff0139e-e7d4-4bcd-b5e5-f1776ed1463b
Set id: 388f7e35-efbe-496b-a8d6-518caa22328d
Version: 1
Effective Time: 20210628
 
H2-Pharma, LLC