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NDC 10157-4645-01 Blistex 1 g/100g Details

Blistex 1 g/100g

Blistex is a TOPICAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by Blistex Inc. 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: 10157-4645-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Tolnaftate

Product Information

NDC	10157-4645
Product ID	10157-4645_0e7d57aa-4f70-48ce-8479-aff4d0c01833
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	Blistex
Proprietary Name Suffix	Odor-Eaters Powder
Non-Proprietary Name	Tolnaftate
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
Route	TOPICAL
Active Ingredient Strength	1
Active Ingredient Units	g/100g
Substance Name	TOLNAFTATE
Labeler Name	Blistex Inc
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part333C
Listing Certified Through	2024-12-31

Package

Package Images

NDC 10157-4645-01 (10157464501)

Pricing Information	N/A
NDC Package Code	10157-4645-1
Billing NDC	10157464501
Package	113 g in 1 CAN (10157-4645-1)
Marketing Start Date	2013-12-09
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 819edb2f-dda7-45c3-b0da-ebcae354154e Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in liquid)

Tolnaftate 1% (to deliver)

Purpose

Antifungal

Uses

prevents most athlete's foot with daily use
clears up most athlete's foot infection and with daily use helps keep it from coming back

Warnings

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

For external use only.

Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F.

If irritation occurs, discontinue use and consult a doctor.

Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

Do not use near fire or flame – flammable mixture.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Shake container well before use.
To prevent athlete's foot, wash the feet and dry thoroughly. Holding can 8" from the skin, spray a thin layer of the product on the feet once or twice daily (morning and/or night). 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.
Wash hands after use.

Inactive ingredients

disteardimonium hectorite, fragrance, isobutane, isopropyl myristate, SD alcohol 40-B, sodium bicarbonate, sodium polyacrylate (crosslinked)

PRINCIPAL DISPLAY PANEL - 113 g Can Label

Odor-

Eaters®

3

ADVANCED

ODOR/WETNESS

FIGHTERS

TALC-FREE

SPRAY

POWDER

Tolnaftate Antifungal

Destroys Odor & Prevents

Most Athlete's Foot

STOPS

ODOR

ALL-DAY

EFFECTIVENESS®

Net Wt.

4 oz. (113 g)

PRINCIPAL DISPLAY PANEL - 113 g Can Label

INGREDIENTS AND APPEARANCE

BLISTEX ODOR-EATERS POWDER

tolnaftate spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10157-4645
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Tolnaftate (UNII: 06KB629TKV) (Tolnaftate - UNII:06KB629TKV)	Tolnaftate	1 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
ISOBUTANE (UNII: BXR49TP611)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:10157-4645-1	113 g in 1 CAN; Type 0: Not a Combination Product	12/09/2013
2	NDC:10157-4645-2	151 g in 1 CAN; Type 0: Not a Combination Product	11/15/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part333C	12/09/2013

Labeler - Blistex Inc (005126354)

Name	Address	ID/FEI	Business Operations
Establishment
Blistex Inc		005126354	MANUFACTURE(10157-4645)

Revised: 12/2021

Document Id: 0e7d57aa-4f70-48ce-8479-aff4d0c01833

Set id: 819edb2f-dda7-45c3-b0da-ebcae354154e

Version: 4

Effective Time: 20211217