KERASAL FOR ATHLETES FOOT SILKY CLEAR- tolnaftate gel

Kerasal for Athletes Foot Silky Clear by

Drug Labeling and Warnings

Kerasal for Athletes Foot Silky Clear by is a Otc medication manufactured, distributed, or labeled by Advantice Health, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

• proven clinically effective in the treatment of most athlete's foot (tinea pedis)
• clinically proven to prevent most Athlete's Foot with daily use
• for effective relief of itching, cracking, burning, scaling and discomfort

Warnings

For external use only

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

When using this product avoid contact with the eyes.

Stop use and ask a doctor if

• irritation occurs
• there is no improvement within 4 weeks.

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
• apply a thin layer over affected area twice daily (morning and night)
• supervise children in the use of this product
• pay special attention to spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily
• use daily for 4 weeks; if condition persists longer, ask a doctor
• to prevent athlete's foot, apply once or twice daily (morning and/or night, or as directed by a doctor)
• this product is not effective on the scalp or nails

Other information

Store between 20-25°C (68-77°F)

Inactive ingredients

aloe vera leaf, alpha tocopheryl acetate, ceramide NG, dimethicone, dimethicone crosspolymer, eucalyptus oil, isododecane, peppermint oil, tea tree oil

Questions?

1-877-674-3475
www.Kerasal.com

PRINCIPAL DISPLAY PANEL - 12 g Tube Carton

NEW

Tolnaftate Antifungal
Kerasal®

For Athlete's Foot

Silky Clear Gel

5 IN 1™

CURES
Most Athlete s Foot

PREVENTS
Recurrence

RELIEVES
Itching, Burning And Scaling

NOURISHES
Improves Skin Appearance

DEODORIZES
With Essential Oils

Enriched with Natural Tea Tree Oil,
Aloe, Ceramides & Vitamin E

NET WT 0.42 oz (12 g)

INGREDIENTS AND APPEARANCE

KERASAL FOR ATHLETES FOOT SILKY CLEAR 
tolnaftate gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 16864-100
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CERAMIDE NG (UNII: C04977SRJ5)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
EUCALYPTUS OIL (UNII: 2R04ONI662)
ISODODECANE (UNII: A8289P68Y2)
PEPPERMINT OIL (UNII: AV092KU4JH)
TEA TREE OIL (UNII: VIF565UC2G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 16864-100-01	1 in 1 CARTON	02/28/2022
1		12 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	02/28/2022

Labeler - Advantice Health, LLC (192527062)