TIOCONAZOLE OINTMENT 6.5%- tioconazole ointment 
DPT Laboratories, Ltd.

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Active ingredient
(in each applicator)
Tioconazole 300 mg (6.5%)

Purpose
vaginal antifungal

Use

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

When using this product

Stop use and ask a doctor if

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

Other information

Inactive ingredients

butylated hydroxyanisole, magnesium aluminum silicate, white petrolatum

Do not use if sealed foil packet torn, open, or incompletely sealed.

1-DOSE TREATMENT
TIOCONAZOLE OINTMENT 6.5%
VAGINAL ANTIFUNGAL

DIRECTIONS FOR USE

Tioconazole_oint_fig1-01

REMOVE PURPLE CAP from top of applicator with a pull-twist action.
Tioconazole_oint_fig2-01


Insert the applicator

Tioconazole_oint_fig3-01

PLEASE READ EDUCATIONAL BROCHURE FOR ADDITIONAL INFORMATION.

4260000 P6

DISTRIBUTED BY
PERRIGO
ALLEGAN, MI 48010 U.S.A.
TIOCONAZOLE  OINTMENT 6.5%
tioconazole ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63094-0426
Route of AdministrationVAGINAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TIOCONAZOLE (UNII: S57Y5X1117) (TIOCONAZOLE - UNII:S57Y5X1117) TIOCONAZOLE65 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63094-0426-15 g in 1 APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07591508/22/2007
Labeler - DPT Laboratories, Ltd. (621782218)
Registrant - DPT Laboratories, Ltd. (621782218)
Establishment
NameAddressID/FEIBusiness Operations
DPT Laboratories, Ltd. 621782218manufacture

Revised: 8/2009
Document Id: 11ddf219-8537-4a8f-b267-ef965159885e
Set id: 11ddf219-8537-4a8f-b267-ef965159885e
Version: 1
Effective Time: 20090831
 
DPT Laboratories, Ltd.