ANTIFUNGAL CREAM- antifungal cream

United States - English - NLM (National Library of Medicine)

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Active ingredient:
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)
Available from:
BluePoint Laboratories
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
- Proven clinically effective in the treatment of athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis) - Proven effective in the prevention of athlete' s foot - effectively soothes and relieves itching associated with jock itch , scaly skin between the toes and burning feet When using this product avoid conatct with eyes Stop use and ask a doctor if - irritation occurs - there is no improvement within 4 weeks - Do not use on children under 2 years of age except under the advice and supervision of a doctor - Do not use for diaper rash Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away.
Authorization status:
OTC monograph final
Authorization number:
68001-478-45, 68001-478-46

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ANTIFUNGAL CREAM- antifungal cream

BluePoint Laboratories

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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1 % Tolnaftate Cream, USP

Active Ingredient

Active Ingredient Purpose

Tolnaftate 1.0% Antifungal

Us es

Proven clinically effective in the treatment of athlete's foot (tinea pedis), jock itch (tinea cruris),

ringworm (tinea corporis)

Proven effective in the prevention of athlete' s foot

effectively soothes and relieves itching associated with jock itch , scaly skin between the toes and

burning feet

Warnings For External use only

When using this product avoid conatct with eyes

Stop use and ask a doctor if

irritation occurs

there is no improvement within 4 weeks

Do not use on children under 2 years of age except under the advice and supervision of a doctor

Do not use for diaper rash

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

away.

Directions

wash affected area and dry thoroughly

apply a thin layer over affected area twice daily (morning and night) or as directy by a doctor.

supervise children in the use of this product.

Dosage and Administration

for athlete's foot: pay special attention to spaces between 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 persist longer consult a doctor

this product is not effective on the scalp or nails

Keep Out Of Reach Of Children

KEEP OUT Of REACH Of CHILDREN

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

INACTIVE INGREDIENTS

Inactive Ingredients: Cetech-20, Cetostearyl alcohol, Chlorocresol, Mineral Oil ( Light Liquid

paraffin), Propylene glycol, Sodium Phosphate, Monobasic,White Soft Paraffin, Purified water.

Contact 1-800-707-4621

Preserve in thight containers. Store as 15

to 30

C ( 59

to 86

F) Lot No. & Rxp.Date. See box

or crimp of the tube

1% Tolnaftate Cream, USP Carton

NDC 68001-478-45

1% Tolnaftate Cream, USP Tube Label

NDC 68001-478-45

ANTIFUNGAL CREAM

antifungal cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 8 0 0 1-478

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

TO LNAFTATE (UNII: 0 6 KB6 29 TKV) (TOLNAFTATE - UNII:0 6 KB6 29 TKV)

TOLNAFTATE

1 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

CETETH-2 0 (UNII: I8 35H2IHHX)

CETO STEARYL ALCO HO L (UNII: 2DMT128 M1S)

LIGHT MINERAL O IL (UNII: N6 K578 7QVP)

CHLO RO CRESO L (UNII: 36 W53O710 9 )

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

SO DIUM PHO SPHATE, DIBASIC, ANHYDRO US (UNII: 22ADO53M6 F)

WATER (UNII: 0 59 QF0 KO0 R)

WHITE PETRO LATUM (UNII: B6 E5W8 RQJ4)

BluePoint Laboratories

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 8 0 0 1-478 -45

1 in 1 CARTON

12/0 3/20 20

1

28 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:6 8 0 0 1-478 -46

1 in 1 CARTON

12/0 3/20 20

2

15 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt333C

11/25/20 20

Labeler -

BluePoint Laboratories (985523874)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Go paldas Visram & Co ., Ltd

8 58 0 30 8 8 8

ma nufa c ture (6 8 0 0 1-478 )

Revised: 12/2020

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