SMOOTH AF- tolnaftate cloth

Smooth AF by

Drug Labeling and Warnings

Smooth AF by is a Otc medication manufactured, distributed, or labeled by Pelli Skin Co.,LLC., Diamond Wipes International. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

proven clinically effective in the treatment of most athlete's foot 9tinea pedis) and ringworm (tinea corporis)

helps prevent most athlete's foot with daily use

for effective relief of itching, burning and cracking

Warnings

For external use only

When using this product

When using this product avoid contact with the eyes.

use only as directed; intentional misuse by deliberately concentrating and inhaling may harmful or fatal

Stop use and ask a doctor

if irritation occurs there is no improvement within 4 weeks

Do not use

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

Keep out of reach of children

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

Directions

wash affected area with soap and water and dry thoroughly

unfold and use towel to thoroughly clean and massage solution into entire foot soles, around and between toes

sue new towel daily for 4 weeks; if condition persists longer, ask a doctor

dispose of uses towel in bin, do not flush

to prevent athlete's foot, use towel as directed once or twice daily (morning and/or night)

for athlete's foot, wear well fitting, ventilated shoes and change shoes and socks at least once daily

this product is not effective on the scalp or nails

Other information

Store between 20°–25°C (68°–77°F)

Inactive ingredients

Water, Propanediol, Dioxolane, Mentha Piperita (Peppermint) Oil, Eucalyptus Globulus Leaf Oil, Gossypium Herbaceum (Cotton) Seed Oil, Sodium Lauroyl Sarcosinate, Sodium Lauroamphoacetate, Ethylhexyl Stearate, Sorbitan Laurate, Polyglyceryl-4 Laurate, Dilauryl Citrate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Tocopheryl Acetate, Disodium EDTA, Phenoxyethanol, Caprylyl Glycol

Questions

info@pelliskin.com

Label

SMOOTH

AF TM

Relief reinvented

Alcohol-free

athlete's foot

cure and

prevention

Advanced anti-fungal medication

NOW WITHOUT THE NEED FOR CREAMS OR SPRAYS

Open up and say ahhhh

30 Treatment Towels

7.0in x 7.75in (17.8cm x 19.6cm)

PODIATRIST RECOMMENDED

SMOOTHAF

A spa day in a towel

A better way to prevent

and cure athlete's foot,

while making feet feel

clean, refreshed and

SMOOTHAF.

The Clean Cure

Podiatrist recommended

anti-fungal medication.

paraben-free, cures and

prevents athlete's foot.

Safe and effective.

Distributed by:

Pelli Skin Co., LLC.

Mission, Texas

getsmoothaf.com

SMOOTHAF

Wipes on clean.

Smells fresh.

Gentle enough to use daily.

Goes anywhere you do.

PATENT

PENDING

APPROVED

AMERICAN PODIATRIC

MEDICAL

ASSOCIATION

PROUDLY

MADE IN THE

USA

PARABEN

FREE

RAINFOREST ALLIANCE

CERTIFIED

MIX Paper

FSC FSC R C109834

INGREDIENTS AND APPEARANCE

SMOOTH AF 
tolnaftate cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73046-613
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
WATER (UNII: 059QF0KO0R)
PROPANEDIOL (UNII: 5965N8W85T)
DIOXOLANE (UNII: Y57RBG19JL)
DISODIUM LAUROAMPHODIACETATE (UNII: R4HKX6I64R)
SODIUM LAURATE (UNII: K146MR5EXO)
COTTONSEED OIL (UNII: H3E878020N)
PEPPERMINT OIL (UNII: AV092KU4JH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
EUCALYPTUS OIL (UNII: 2R04ONI662)
DILAURYL CITRATE (UNII: 5OYS3G306B)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Product Characteristics
Color	white (Cloth)	Score
Shape	RECTANGLE	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73046-613-03	1 g in 1 POUCH; Type 0: Not a Combination Product	07/11/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	07/11/2019

Labeler - Pelli Skin Co.,LLC. (117027673)

Registrant - Diamond Wipes International (161104729)

Establishment
Name	Address	ID/FEI	Business Operations
Diamond Wipes International		161104729	manufacture(73046-613)