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| NDC | 0145-1501-03, 0145-1506-01, 0145-1506-05, 0145-1506-61 |
| Set ID | c8260a34-ea4d-46d9-b9de-0cdd689be5c9 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Stiefel Laboratories Inc |
| Generic Name | |
| Product Class | Azole Antifungal |
| Product Number | |
| Application Number | PART333C |
- Active ingredient
- Purpose
- Use (Athlete's Foot)
- Use (Jock Itch)
- Warnings
For external use only
Do not use
- •
- on children under 2 years of age unless directed by a doctor.
Avoid contact with the eyes.
Stop use and ask a doctor if (Athlete's Foot)
- •
- irritation occurs or there is no improvement within 4 weeks.
Stop use and ask a doctor if (Jock Itch)
- •
- irritation occurs or there is no improvement within 2 weeks.
CloseKeep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
- Directions (Athlete's Foot)
- •
- clean the affected area and dry thoroughly
- •
- apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor
- •
- supervise children in the use of this product
- •
- pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
- •
- use daily for 4 weeks
- •
- if condition persists longer, consult a doctor
- •
- this product is not effective on the scalp or nails
- Directions (Jock Itch)
- •
- clean the affected area and dry thoroughly.
- •
- apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor. Avoid open wounds.
- •
- supervise children in the use of this product.
- •
- use daily for 2 weeks.
- •
- if condition persists longer, consult a doctor.
- •
- this product is not effective on the scalp or nails.
- Other information
- Inactive ingredients
- Questions?
call 1-888-438-7426
Distributed by: Stiefel Laboratories, Inc., Research Triangle Park, NC 27709
Made in India
Trademarks are owned by or licensed to the GSK group of companies.
Close - Principal Display Panel
NDC 0145-1506-05
Super Absorbent Powder
Zeasorb® AF
ANTIFUNGAL TREATMENT
Miconazole Nitrate 2%
Super Absorbent Powder
cures most athlete's foot
Relieves:
- •
- Itching
- •
- Burning
- •
- Scaling
#1 Dermatologist Recommended
Stiefel
Net wt. 2.5 OZ (71 g)
©2015 GSK or its licensor. All rights reserved.
Front Label: 103580XC
Close - Principal Display Panel
NDC 0145-1501-03
Super Absorbent Powder
Zeasorb® AF
ANTIFUNGAL TREATMENT
Miconazole Nitrate 2%
cures most jock itch
Relieves:
- •
- Itching
- •
- Burning
- •
- Scaling
#1 Dermatologist Recommended
Stiefel
Net wt. 2.5 OZ (71 g)
©2015 GSK or its licensor. All rights reserved
Front Label: 103658XB
Close - INGREDIENTS AND APPEARANCE
ZEASORB
miconazole nitrate powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0145-1506 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 20.6 mg in 1 g Inactive Ingredients Ingredient Name Strength ALDIOXA (UNII: 8T66I31YNK) CHLOROXYLENOL (UNII: 0F32U78V2Q) IMIDUREA (UNII: M629807ATL) POWDERED CELLULOSE (UNII: SMD1X3XO9M) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color WHITE (white to off-white) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0145-1506-05 71 g in 1 BOTTLE; Type 0: Not a Combination Product 03/14/2011 05/31/2020 2 NDC:0145-1506-01 20 in 1 CARTON 03/14/2011 05/31/2020 2 NDC:0145-1506-61 2.8 g in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 03/14/2011 05/31/2020 ZEASORB
miconazole nitrate powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0145-1501 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 20.6 mg in 1 g Inactive Ingredients Ingredient Name Strength ALDIOXA (UNII: 8T66I31YNK) CHLOROXYLENOL (UNII: 0F32U78V2Q) IMIDUREA (UNII: M629807ATL) POWDERED CELLULOSE (UNII: SMD1X3XO9M) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color WHITE (white to off-white) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0145-1501-03 71 g in 1 BOTTLE; Type 0: Not a Combination Product 03/14/2011 05/31/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 03/14/2011 05/31/2020 CloseLabeler - Stiefel Laboratories Inc (808842343)
