CLOTRIMAZOLE (TOPICAL SOLUTION), 1%- clotrimazole solution 
Puro Pharma Inc.

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Clotrimazole (Topical Solution) USP, 1%

Drug Facts

Active ingredient

Clotrimazole USP, 1%

Purpose

Antifungal

Uses

Cures most
• Athlete's foot (tinea pedis)
• Jock itch (tinea cruris)
• Ringworm (tinea corporis)

Effectively relieves
• itching • cracking • burning • discomfort which can accompany these conditions.

Warnings

For external use only.

Ask a doctor before use
• on children under 2 years of age

When using this product
• avoid contact with eyes

Stop use and ask a doctor if
• irritation occurs
• there is no improvement within 4 weeks (for athlete's foot and ringworm) or 2 weeks (for jock itch)

Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• This product is not effective on the scalp or nails. For best results, follow directions and continue treatment for length of time indicated. For athlete's foot and ringworm: use daily for 4 weeks. For jock itch: use daily for 2 weeks.
• clean the affected area and dry thoroughly
• apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor
• supervise children in the use of this product.
For athlete's foot: pay special attention to spaces between the toes: wear well-fitting, ventilated shoes; change shoes and socks at least once daily.

Other information

• store between 15°-30°C (59°-86°F)

Inactive ingredient

polyethylene glycol

Questions or comments?

Call 1-(845) 450-0141
Mon-Fri 9:00AM to 5:00PM EST

Compare to the active ingredient in Lotrimin® AF*

Greaseless, Nonstaining

Not for Ophthalmic use.

Keep this and all medications out of the reach of children.

TAMPER EVIDENT: This bottle has an imprinted seal around the neck. Do not use if seal is damaged or missing at the time of purchase.

*All trademarks are property of their respective owners. This product is not affiliated with the makers/owners of Lotrimin® AF.

Keep this carton for important information.

Distributed by:
Puro Pharma Inc.

Poughkeepsie, NY 12601

Packaging

Clotrimazole-003

CLOTRIMAZOLE (TOPICAL SOLUTION), 1% 
clotrimazole solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83474-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83474-003-341 in 1 CARTON04/15/2024
110 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00504/15/2024
Labeler - Puro Pharma Inc. (128518845)

Revised: 4/2024
Document Id: e7a22b39-82a1-46ff-8690-4d9e8b04413f
Set id: cb424fa8-3ed5-45cd-b03f-64675584b34e
Version: 1
Effective Time: 20240408
 
Puro Pharma Inc.