Antifungal by Moore Medical LLC / Safetec of America, Inc. Antifungal Cream

Drug Details [pdf]

ANTIFUNGAL- tolnaftate cream
Moore Medical 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.

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Antifungal Cream

First Aid

Drug Facts

Active Ingredient (in each gram)

Tolnaftate (1%)

Purpose

Antifungal

Uses:

Cures most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis).
With daily use, helps prevent most athlete's foot and helps keep it from coming back.
For relief of itching or chaffing associated with jock itch, itchy, scaly skin between the toes or itching, burning feet.

Warnings

For external use only

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

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

When using this product avoid contact with eyes

Stop use and consult a doctor if

irritation occurs
there is no improvement within 4 weeks (in the case of athlete's foot or ringworm) or within 2 weeks (in the case of jock itch).

Directions:

Supervise children in the use of this product
Clean the affected area and dry thoroughly.
Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor.
For the treatment or prevention of athlete's foot: Pay special attention to the 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 2 weeks. If the condition lasts longer, consult a doctor.
For jock itch: Use daily for 2 weeks. If the condition lasts longer, consult a doctor.
To prevent athlete's foot: Apply a thin layer of the product to the feet once or twice daily (morning and/or night).
This product is not effective on the scalp or nails.

Other Information:

store at 59-86°F (15-30°C)

Inactive ingredients:

cetyl alcohol, chloroxylenol, glycereth-26, mineral oil, petrolatum, sodium citrate, water.

Questions or Comments? 1-800-234-1464

PRINCIPAL DISPLAY PANEL – 144 count box

mooremedical
Supporting Health & Care

Reorder No. 82481
UPN# 0-0607415-82481-0

MooreBrand
Antifungal Cream
144 Packets
Each Packet Net. Wt. 0.9gm

Soothes and relieves itching,
chafing and burning associated
with athlete's foot, jock itch or
ringworm

To reorder:
Call: 1-800-234-1464
Fax: 1-800-944-6667
Online:
www.mooremedical.com

ANTIFUNGAL
tolnaftate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55670-602
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	10 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERETH-26 (UNII: NNE56F2N14)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
CHLOROXYLENOL (UNII: 0F32U78V2Q)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 55670-602-01	144 in 1 BOX	07/16/2012	11/07/2019
1		0.9 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333C	07/16/2012	11/07/2019

Labeler - Moore Medical LLC (051420107)

Registrant - Safetec of America, Inc. (874965262)

Name	Address	ID/FEI	Business Operations
Establishment
Safetec of America, Inc.		874965262	manufacture(55670-602)

Revised: 11/2019

Document Id: 96c3ae70-5fe1-4782-e053-2a95a90a5659

Set id: b5c24e09-dba0-4dc2-bd48-df34692e34a6

Version: 4

Effective Time: 20191107

Moore Medical LLC