ANTIFUNGAL POWDER- miconazole nitrate powder

Antifungal Powder by

Drug Labeling and Warnings

Antifungal Powder by is a Otc medication manufactured, distributed, or labeled by Aldermed Inc., Gopaldas Visram and Company Limited. Address. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Active Ingredient                     

Miconazol Nitrate 2%                         

Purpose

Antifungal

Uses

Proven clinically effective in the treatment of most: athlete's foot jock itch ringworm Relieves itching, scaling, cracking, burning, redness, soreness, irrita-tion, and discomforts associated with all three treatments. Also relieves chaffing associated with jock itch.

Warnings

For external use only.

Do Not Use

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

When using this product

Avoid contact with eyes

Stop use and ask a doctor if

■ irritation occurs

■ there is no improvement I within 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch)

Directions

■ clean affected area and dry thoroughly

■ apply thin layer of powder to affected area twice daily (morning and night) or as direct-ed by a doctor

■ supervise children in the use of this product

■ for athlete's foot pay special attention to space between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily

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

this product is not effective on the scalp or nail

Other information

Store at room temperature

Keep Out Of Reach Of Children

Keep Out Of Reach Of Children

Do not let the powder get into your eyes. This product contains talc. Do not breathe in the powder as this may cause irritation of the airways. This is especially important for children and infants. If swallowed, contact a poison control center immediately.

Inactive ingredients

Colloidal silicon dioxide, Corn Starch, Dipotassium Glycyrhizinate, Sodium Benzoate

Principal Display panel

INGREDIENTS AND APPEARANCE

ANTIFUNGAL POWDER 
miconazole nitrate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87236-012
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
DIPOTASSIUM GLYCYRRHIZATE (UNII: CA2Y0FE3FX)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87236-012-03	85 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	12/01/2025

Labeler - Aldermed Inc. (144887712)

Registrant - Aldermed Inc. (144887712)

Establishment
Name	Address	ID/FEI	Business Operations
Gopaldas Visram and Company Limited. Address		858030888	manufacture(87236-012)