TOLNAFTATE- tolnaftate cream

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

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Active ingredient:
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)
Available from:
Cardinal Health LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antifungal Cream - Cures most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis). - Relieves the  itching, irratation, redness, scaling and discomfort which can accompany these conditions.
Authorization status:
OTC monograph final
Authorization number:
70000-0494-1

TOLNAFTATE- tolnaftate cream

Cardinal Health LLC

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.

----------

Drug Facts

Active ingredient

Tolnaftate USP 1%

Purpos e

Antifungal Cream

Us es

Cures most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis).

Relieves the itching, irratation, redness, scaling and discomfort which can accompany these

conditions.

Warnings

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

For external use only avoid contact with eyes.

Irritation occurs or if there is no improvement within 4 weeks (for athlete's foot and

ringworm)irritation occurs or if there is no improvement within 2 weeks (for jock itch).

Keep this and all drugs out of the reach of children.In case of accidental ingestion, seek professional

assistance or contact a Poison Control Center immediately.

Directions

Clean the affected area and dry thoroughly.

Apply a thin layer of the product over the affected area twice daily (morning and night) or as

directed by a doctor.

Supervise children in the use of this product.

For athlete's foot

Pay special attention to the 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.

Other information

Store at controlled room temperature 15°-30°C (59°-86°F).

Close cap tighty after ever use.

Inactive ingredients

Ceteth-20, Cetostearyl Alcohol, Chlorocresol, Mineral Oil, White Petrolatum, Propylene

Glycol, Sodium Phosphate Monobasic, Water

Ques tions ?

1-800-222-1222

Principal Display Panel – 1.0 oz Tube

LEADER NDC 70000-0494-1

Compare to Tinactin

CURES Most:

ATHLETE'S FOOT

Net Wt. 1.0 OZ (28 g)

Principal Display Panel – 1.0 oz Carton

LEADER NDC 70000-0494-1

Antifungal Cream (Tolnaftate 1%)

CURES Most:

ATHLETE'S FOOT

Net Wt. 1.0 OZ (28 g)

TOLNAFTATE

tolnaftate cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:70 0 0 0 -0 49 4

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

10 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

Cardinal Health LLC

WATER (UNII: 0 59 QF0 KO0 R)

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

CETETH-2 0 (UNII: I8 35H2IHHX)

CHLO RO CRESO L (UNII: 36 W53O710 9 )

MINERAL O IL (UNII: T5L8 T28 FGP)

PETRO LATUM (UNII: 4T6 H12BN9 U)

SO DIUM PHO SPHATE, MO NO BASIC, ANHYDRO US (UNII: KH7I0 4HPUU)

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

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:70 0 0 0 -0 49 4-1

1 in 1 CARTON

0 5/15/20 19

1

28 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

0 5/15/20 19

Labeler -

Cardinal Health LLC (097537435)

Registrant -

Sheffield Pharmaceuticals LLC (151177797)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Sheffield Pharmaceuticals LLC

15117779 7

MANUFACTURE(70 0 0 0 -0 49 4)

Revised: 5/2019

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