ASTONEA MICONAZOLE NITRATE- antifungal powder 
ASTONEA LABS PRIVATE LIMITED

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Astonea Anti-Fungal Powder Talc

Active Ingredients

Miconazole nitrate 2%

Purpose

Antifungal

Uses

fFor the treatment of most athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis) ■Relieves itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch or itching, burning feet

Warnings

For external use only.

Do not use

: ■On children under 2 years of age unless directed by a doctor ■For diaper rash

When using this product

avoid contact with the eyes

Stop use and ask a doctor if

■Irritation occurs

■There is no improvement within 2 weeks when used for the treatment of jock itch ■There is no improvement within 4 weeks when used for athlete's foot or ringworm

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

Colloidal Anhyhdrous Silica, Talcum Powder

Questions?

Call 1-866-964-0939

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ASTONEA MICONAZOLE NITRATE 
antifungal powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77338-165
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TALC (UNII: 7SEV7J4R1U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77338-165-0385 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/19/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00508/19/2022
Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)

Revised: 6/2024
Document Id: 1bbac946-d7d1-b388-e063-6294a90a812e
Set id: e69cd379-fdb2-b737-e053-2995a90aba3e
Version: 2
Effective Time: 20240625
 
ASTONEA LABS PRIVATE LIMITED