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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)

Available from:

Derma Care Research Labs, LLC

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antifungal 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.

Authorization status:

OTC monograph final

Summary of Product characteristics

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._
----------
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
ANTI-FUNGAL BUTTERY BALM LADY BITS
miconazole nitrate 2% ointment
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:728 39 -133
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
MICO NAZO LE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0
D7S5M)
MICONAZOLE NITRATE
2 g in 10 0 g
INACTIVE INGREDIENTS
Derma Care Research Labs, LLC
INGREDIENT NAME
STRE NG TH
ALTHAEA O FFICINALIS RO O T (UNII: TRW2FUF47H)
CO CO NUT O IL (UNII: Q9 L0 O73W7L)
CALENDULA O FFICINALIS FLO WER (UNII: P0 M7O4Y7YD)
CO CO A (UNII: D9 10 8 TZ9 KG)
VANILLA (UNII: Q74T350 78 H)
WATER (UNII: 0 59 QF0 KO0 R)
MELO N (UNII: 5CIT1X6 U5V)
YELLO W WA