CLOTRIMAZOLE- clotrimazole solution 
Akron Pharma Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Clotrimazole Topical Solution USP,1%

Drug Facts

Active ingredient

Clotrimazole USP, 1%

Purpose

Antifungal

Uses

Cures most

Effectively relieves

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

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

Inactive ingredient

polyethylene glycol 400

Questions?

Please Call 1-877-225-6999

PRINCIPAL DISPLAY PANEL - 10 mL Bottle Carton

NDC 71399-0500-1

Compare to the active ingredient of Lotrimin®AF*

Clotrimazole Topical Solution USP,1%

Antifungal

For External use only.
Not for Opthalmic use.

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

Akron Pharma

10ml

Label​​​

CLOTRIMAZOLE 
clotrimazole solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71399-0500
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Clotrimazole (UNII: G07GZ97H65) (Clotrimazole - UNII:G07GZ97H65) Clotrimazole1 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
polyethylene glycol 400 (UNII: B697894SGQ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71399-0500-110 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333C05/15/2017
Labeler - Akron Pharma Inc (067878881)
Registrant - Akron Pharma Inc (067878881)
Establishment
NameAddressID/FEIBusiness Operations
SLV PHARMACEUTICALS LLC081225162manufacture(71399-0500)

Revised: 11/2019
Document Id: 4a2aebe0-e3dc-4085-8672-1dabcc822a0b
Set id: 692d7e0f-50d4-4abb-8c74-36bc98064fe7
Version: 2
Effective Time: 20191120
 
Akron Pharma Inc