ANTI-FUNGAL BUTTERY BALM LADY BITS- miconazole nitrate 2% ointment 
Derma Care Research Labs, LLC

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.

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Miconazole Nitrate 2%

Antifungal

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

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.

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.

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

Carton

ANTI-FUNGAL BUTTERY BALM  LADY BITS
miconazole nitrate 2% ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72839-133
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72839-133-0125 g in 1 JAR; Type 0: Not a Combination Product05/03/201912/31/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C05/03/201912/31/2021
Labeler - Derma Care Research Labs, LLC (116817470)

Revised: 1/2023
 
Derma Care Research Labs, LLC