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NDC 46063-0810-12 Relispray Antifungal Liquid 0.01 g/g Details

Relispray Antifungal Liquid 0.01 g/g

Relispray Antifungal Liquid is a TOPICAL AEROSOL, SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by Midas-Care Pharmaceuticals Pvt. Ltd.. 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: 46063-0810-12
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Tolnaftate

Product Information

NDC	46063-0810
Product ID	46063-810_db53482a-fdb4-4130-85b4-23604ded9996
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	Relispray Antifungal Liquid
Proprietary Name Suffix	n/a
Non-Proprietary Name	Tolnaftate
Product Type	HUMAN OTC DRUG
Dosage Form	AEROSOL, SPRAY
Route	TOPICAL
Active Ingredient Strength	0.01
Active Ingredient Units	g/g
Substance Name	TOLNAFTATE
Labeler Name	Midas-Care Pharmaceuticals Pvt. Ltd.
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 46063-0810-12 (46063081012)

Pricing Information	N/A
NDC Package Code	46063-810-12
Billing NDC	46063081012
Package	128 g in 1 CAN (46063-810-12)
Marketing Start Date	2022-03-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 6522ad59-f810-408c-a9f9-9359d79302ce Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

effectively treats most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)
relieves itching, scaling, burning and discomfort which may accompany these conditions

Warnings

For external use only

Flammable. Do not use while smoking or near heat or flame.

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

When using this product

avoid contact with the eyes
use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal
do not puncture or incinerate. Contents under pressure.

Do not store at temperatures above 120°F

Stop use and ask a doctor if

irritation occurs
there is no improvement within 4 weeks (for athlete's foot and ringworm) or 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

wash the affected area and dry thoroughly
shake can well and apply a thin layer over the affected area twice daily (morning and night)
supervise children in the use of this product
for athlete's foot:
- pay special attention to spaces between the toes
- wear well-fitting, ventilated shoes
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

Inactive ingredients

Butylated hydroxytoluene, fragrance, polyethylene glycol 400, propellant (isobutane, normal butane, propane), SD alcohol 40-B (41% w/w)

Questions or comments?

Call 888-491-1965

PRINCIPAL DISPLAY PANEL - 128 g Can Label

NDC 46063-810-12

Relispray

Antifungal

Spray

Liquid

Tolnaftate 1%

Antifungal Spray

Liquid

Net Wt 4.5 oz (128g)

PRINCIPAL DISPLAY PANEL - 128 g Can Label

INGREDIENTS AND APPEARANCE

RELISPRAY ANTIFUNGAL LIQUID

tolnaftate aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:46063-810
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Tolnaftate (UNII: 06KB629TKV) (Tolnaftate - UNII:06KB629TKV)	Tolnaftate	0.01 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
Butylated hydroxytoluene (UNII: 1P9D0Z171K)
FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)
Polyethylene glycol 400 (UNII: B697894SGQ)
LIQUEFIED PETROLEUM GAS (UNII: 5K616HU99V)
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:46063-810-12	128 g in 1 CAN; Type 0: Not a Combination Product	03/01/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part333C	03/01/2022

Labeler - Midas-Care Pharmaceuticals Pvt. Ltd. (862273427)

Revised: 1/2022

Document Id: db53482a-fdb4-4130-85b4-23604ded9996

Set id: 6522ad59-f810-408c-a9f9-9359d79302ce

Version: 1

Effective Time: 20220128