ROMMY JEAN-PIERRE LLC ANTI-FUNGAL CREAM- miconazole nitrate cream cream

RoMMY Jean-Pierre LLC Anti-fungal Cream by

Drug Labeling and Warnings

RoMMY Jean-Pierre LLC Anti-fungal Cream by is a Otc medication manufactured, distributed, or labeled by RoMMY Jean-Pierre LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Miconazole nitrate 2%
Sulfur 5%
Camphor 1%
Menthol 1%

Purpose

Antifungal
Keratolytic
External Analgesic

INDICATIONS & USAGE

Cures most athlete’s foot, jock itch, and ringworm
Relieves itching, burning, cracking, and scaling associated with these conditions
Helps relieve itching and discomfort associated with minor skin irritation
Helps loosen and remove excessive dead skin and flakes

WARNINGS

For external use only

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

When using this product avoid contact with eyes
do not apply to broken or severely irritated skin

Stop use and ask a doctor if:
irritation occurs
condition worsens
symptoms persist for more than 4 weeks

Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.

WHEN USING

Avoid contact with eyes
Do not apply to broken or severely irritated skin

DO NOT USE

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

STOP USE

Stop use and ask a doctor if irritation occurs or if condition worsens

DOSAGE & ADMINISTRATION

Clean and dry the affected area before applying
Apply a thin layer to the affected area twice daily (morning and night)
For athlete’s foot and ringworm, use daily for 4 weeks
For jock itch, use daily for 2 weeks
If condition persists longer, consult a doctor

STORAGE AND HANDLING

Store at 20°–25°C (68°–77°F)
Excursions permitted between 15°–30°C (59°–86°F)
Protect from excessive heat and direct sunlight
Do Not Freeze

INACTIVE INGREDIENT

Aloe barbadensis leaf juice, carthamus tinctorius (safflower) seed oil, petrolatum, peppermint oil, thymol, alpha-tocopherol acetate

QUESTIONS

Questions or comments?
Email romy.jean-pierre@rommyllc.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ROMMY JEAN-PIERRE LLC ANTI-FUNGAL CREAM 
miconazole nitrate cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87306-126
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	1 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 g  in 100 g
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	2 g  in 100 g
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PETROLATUM (UNII: 4T6H12BN9U)
THYMOL (UNII: 3J50XA376E)
PEPPERMINT OIL (UNII: AV092KU4JH)
CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL (UNII: 65UEH262IS)
ALOE BARBADENSIS LEAF JUICE (UNII: RUE8E6T4NB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87306-126-01	113.4 g in 1 JAR; Type 0: Not a Combination Product	02/08/2026
2	NDC: 87306-126-02	56.7 g in 1 JAR; Type 0: Not a Combination Product	02/08/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	02/08/2026

Labeler - RoMMY Jean-Pierre LLC (139220877)

Registrant - RoMMY Jean-Pierre LLC (139220877)

Establishment
Name	Address	ID/FEI	Business Operations
RoMMY Jean-Pierre LLC		139220877	label(87306-126) , manufacture(87306-126) , pack(87306-126)