TRIPLE AF- miconazole nitrate paste

TRIPLE by

Drug Labeling and Warnings

TRIPLE by is a Otc medication manufactured, distributed, or labeled by Summers Laboratories Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENT

MICONAZOLE NITRATE 2%

PURPOSE

PURPOSE

ANTIFUNGAL

INDICATIONS & USAGE

Uses

• For the treatment of superficial skin infections caused by yeast (Candida albicans).
• Relieves discomfort, irritation, redness and chafing associated with jock itch
• Cures most jock itch (tinea cruris)

WARNINGS

WARNINGS

FOR EXTERNAL USE ONLY

WHEN USING

When using this product avoid contact with eyes

STOP USE

Stop use and ask a doctor if

• irritation occurs
• there is no improvement within 2 weeks

DO NOT USE

Do not use on children under 2 years of age unless directed by a doctor.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

IF SWALLOWED, GET MEDICAL HELP OR CONTCT A POISON CONTROL CENTER RIGHT AWAY.

DOSAGE & ADMINISTRATION

Directions

• Clean affected area and dry thoroughly
• Apply a thin layer of product over affected area twice daily (morning and night) or as directed by a doctor
• Supervise children in the use of this product
• Use daily for 2 weeks; If condition persists longer, consult a doctor
• This product is not effective on the scalp or nails

INACTIVE INGREDIENT

Inactive ingredients

White petrolatum, zinc oxide, corn starch, anhydrous lanolin, stearyl alcohol, beeswax, cholesterol, polysorbate 80.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TRIPLE  AF
miconazole nitrate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11086-040
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
ZINC OXIDE (UNII: SOI2LOH54Z)
STARCH, CORN (UNII: O8232NY3SJ)
LANOLIN (UNII: 7EV65EAW6H)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
YELLOW WAX (UNII: 2ZA36H0S2V)
CHOLESTEROL (UNII: 97C5T2UQ7J)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11086-040-01	28.7 g in 1 TUBE; Type 0: Not a Combination Product	10/30/2013
2	NDC: 11086-040-02	57 g in 1 TUBE; Type 0: Not a Combination Product	10/30/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	10/30/2013

Labeler - Summers Laboratories Inc (002382612)

Establishment
Name	Address	ID/FEI	Business Operations
Summers Laboratories Inc		002382612	manufacture(11086-040) , pack(11086-040)