Clotrimazole by STRATEGIC SOURCING SERVICES LLC CLOTRIMAZOLE cream

Clotrimazole by

Drug Labeling and Warnings

Clotrimazole by is a Otc medication manufactured, distributed, or labeled by STRATEGIC SOURCING SERVICES LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Clotrimazole USP 1% (50 mg in each applicatorful)	Vaginal antifungal
Clotrimazole USP 1% (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 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: 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

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

Questions or comments?

call 833-358-6431

SPL UNCLASSIFIED SECTION

Distributed by:McKesson Corp.,
via Strategic Sourcing Services LLC.
Memphis, TN 38141

PRINCIPAL DISPLAY PANEL - 45 g Tube Carton

Foster & Thrive™

7 DAY TREATMENT

7 Day Vaginal Cream

Clotrimazole Vaginal Cream USP 1%
VAGINAL ANTIFUNGAL

Cures Most Vaginal Yeast Infections

• Educational Brochure Enclosed

One 45 g (1.5 oz) Tube of Clotrimazole Vaginal Cream USP 1% & 1 Reusable Applicator

INGREDIENTS AND APPEARANCE

CLOTRIMAZOLE 
clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70677-1262
Route of Administration	VAGINAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)	CLOTRIMAZOLE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
OCTYLDODECANOL (UNII: 461N1O614Y)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ESTERS WAX (UNII: D072FFP9GU)
POLYSORBATE 60 (UNII: CAL22UVI4M)
WATER (UNII: 059QF0KO0R)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70677-1262-1	1 in 1 CARTON	11/07/2024
1		45 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA072641	11/07/2024

Labeler - STRATEGIC SOURCING SERVICES LLC (116956644)