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NDC 68001-0478-45 Antifungal Cream 1 g/100g Details
Antifungal Cream 1 g/100g
Antifungal Cream is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by BluePoint Laboratories. The primary component is TOLNAFTATE.
MedlinePlus Drug Summary
Tolnaftate stops the growth of fungi that cause skin infections, including athlete's foot, jock itch, and ringworm. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
Related Packages: 68001-0478-45Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Tolnaftate
Product Information
NDC | 68001-0478 |
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Product ID | 68001-478_de323ea4-a5eb-123b-e053-2a95a90ae9a6 |
Associated GPIs | |
GCN Sequence Number | n/a |
GCN Sequence Number Description | n/a |
HIC3 | n/a |
HIC3 Description | n/a |
GCN | n/a |
HICL Sequence Number | n/a |
HICL Sequence Number Description | n/a |
Brand/Generic | n/a |
Proprietary Name | Antifungal Cream |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | antifungal |
Product Type | HUMAN OTC DRUG |
Dosage Form | CREAM |
Route | TOPICAL |
Active Ingredient Strength | 1 |
Active Ingredient Units | g/100g |
Substance Name | TOLNAFTATE |
Labeler Name | BluePoint Laboratories |
Pharmaceutical Class | n/a |
DEA Schedule | n/a |
Marketing Category | OTC MONOGRAPH FINAL |
Application Number | part333C |
Listing Certified Through | 2023-12-31 |
Package
Package Images




NDC 68001-0478-45 (68001047845)
NDC Package Code | 68001-478-45 |
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Billing NDC | 68001047845 |
Package | 1 TUBE in 1 CARTON (68001-478-45) / 28.4 g in 1 TUBE |
Marketing Start Date | 2020-12-03 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL b5904d39-ba21-525b-e053-2a95a90a61f3 Details
Uses
Warnings For External use only
- Do not use on children under 2 years of age unless directed by a doctor
For external use only
When using this productavoid conatct with the eyes
Stop use and ask a doctor if
- irritation occurs
- there is no improvement within 4 weeks (for athlete's foot and ringworm) or within 2 weeks (for jock itch)
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Dosage and Administration
- for athlete's foot: pay special attention to spaces 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 nails
Keep Out Of Reach Of Children
INACTIVE INGREDIENTS
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
ANTIFUNGAL CREAM
antifungal cream |
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Labeler - BluePoint Laboratories (985523874) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Gopaldas Visram & Co., Ltd | 858030888 | manufacture(68001-478) |
Revised: 5/2022
Document Id: de323ea4-a5eb-123b-e053-2a95a90ae9a6
Set id: b5904d39-ba21-525b-e053-2a95a90a61f3
Version: 2
Effective Time: 20220504