HEALSURE CLOTRIMAZOLE- clotrimazole1%, miconazole1%clotrimazole cream

HEALSURE Clotrimazole by

Drug Labeling and Warnings

HEALSURE Clotrimazole by is a Otc medication manufactured, distributed, or labeled by Jiangxi Hemei Pharmaceutical Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Clotrimazole 1%

Miconazole1%

Purpose

Antifungal

Use

·cures most athlete's foot between the toes. Effectiveness on the bottom or sides of foot is unknown

·cures most jock itch and ringworm

·relieves itching.burning, cracking, and scaling which accompany these conditions

Warnings

For external use only

Do not use

·on nails or scalp

· in or nearthe mouth or the eyes

· for vaginal yeast infections

When Using

When using this product do not get into the eyes. lf eye contact occurs, rinse thoroughly with water.

Stop Use

Stop use and ask a doctor if too much irritation occurs or irritation gets worse

Ask Doctor

for jock itch and ringworm: apply once a day to affected skin for 2 weeks or asdirected by a doctor

·wash hands after each use

·children under 12 years: ask a doctor

Keep Oot Of Reach Of Children

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

Directions

·adults and children 12 years and older:· use the tip of the cap to break the seal and open the tube

·wash the affected skin with soap and water and dry completely before applying

· for athlete's foot between the toes:apply to affected skin between and around the toes twice a day for 1 week(morning and night), or once a day for 4 weeks, or as directed by a doctor. Wearwell-fitting, ventilated shoes. Change shoes and socks at least once daily.
for jock itch and ringworm: apply once a day to affected skin for 2 weeks or asdirected by a doctor

·wash hands after each use ·children under 12 years: ask a doctor

Other information

·Do not use if seal on tube is broken or not visible.·store between 20° to 25°℃(68° to 77°F)

Inactive ingredients

Camphor (SYNTHETIC), Gentiana, Glycerin, Methylpareben, Peppermint,Propylene Glycol, Silicone Oil, Triethanolamine.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HEALSURE CLOTRIMAZOLE 
clotrimazole1%, miconazole1%clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84010-085
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)	CLOTRIMAZOLE	1 g  in 100 g
MICONAZOLE (UNII: 7NNO0D7S5M) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
PEPPERMINT (UNII: V95R5KMY2B)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TROLAMINE (UNII: 9O3K93S3TK)
GENTIANA MANSHURICA ROOT (UNII: C1F2NZ8U3L)
DIMETHICONE (UNII: 92RU3N3Y1O)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
METHYLPARABEN (UNII: A2I8C7HI9T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84010-085-01	20 g in 1 BOTTLE; Type 0: Not a Combination Product	03/11/2025
2	NDC: 84010-085-02	30 g in 1 BOTTLE; Type 0: Not a Combination Product	03/11/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	03/11/2025

Labeler - Jiangxi Hemei Pharmaceutical Co., Ltd (724892056)

Establishment
Name	Address	ID/FEI	Business Operations
Jiangxi Hemei Pharmaceutical Co., Ltd		724892056	manufacture(84010-085)