ANTI-FUNGAL BUTTERY BALM LADY BITS- miconazole nitrate 2% ointment

Anti-Fungal Buttery Balm by

Drug Labeling and Warnings

Anti-Fungal Buttery Balm by is a Otc medication manufactured, distributed, or labeled by Derma Care Research Labs, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Miconazole Nitrate 2%

PURPOSE

Antifungal

DOSAGE & ADMINISTRATION

Cures most tinea cruris "jock itch" and tinea corporis "ring worm". Soothes itching, burning, cracking.

WARNINGS

For external use only.

Avoid contact with eyes. 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.

INDICATIONS & USAGE

Clean the affected area thoroughly. Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor. If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor.

INACTIVE INGREDIENT

aloe barbadensis leaf extract, althaea officinalis root extract, beeswax, butyrospermum park ii (shea) butter, calendula officinalis flower extract, cocos nucifera (coconut) oil, cucumis melo (melon) fruit extract, dipteryx odorata seed extract, glycerin, hydrogenated vegetable oil, olea europaea (olive) fruit oil, pimpinella anisum (anise) fruit extract, ricinus communis (castor) seed oil, theobroma cacao (cocoa) extract, triethyl citrate, vanilla planifolia fruit extract, water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANTI-FUNGAL BUTTERY BALM  LADY BITS
miconazole nitrate 2% ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72839-133
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
ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)
COCONUT OIL (UNII: Q9L0O73W7L)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
COCOA (UNII: D9108TZ9KG)
VANILLA (UNII: Q74T35078H)
WATER (UNII: 059QF0KO0R)
MELON (UNII: 5CIT1X6U5V)
YELLOW WAX (UNII: 2ZA36H0S2V)
DIPTERYX ODORATA SEED (UNII: D43A5L1U6L)
GLYCERIN (UNII: PDC6A3C0OX)
CORN OIL (UNII: 8470G57WFM)
RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX)
SHEA BUTTER (UNII: K49155WL9Y)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
OLIVE OIL (UNII: 6UYK2W1W1E)
ANISE (UNII: 21C2F5E8RE)
COCOA BUTTER (UNII: 512OYT1CRR)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72839-133-01	25 g in 1 JAR; Type 0: Not a Combination Product	05/03/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	05/03/2019

Labeler - Derma Care Research Labs, LLC (116817470)