PEDIKLEER- tolnaftate cream

Pedikleer by

Drug Labeling and Warnings

Pedikleer by is a Otc medication manufactured, distributed, or labeled by Rising Pharma Holdings, Inc., Elysium Pharmaceuticals Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts Active Ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

• proven clinically effective in the treatment of most athlete's foot (tinea 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.

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

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

Directions

• wash affected area and dry thoroughly 
• apply a thin layer over 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 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) 
• this product is not effective on the scalp or nails

Other Information 

• TAMPER EVIDENT: DO NOT USE IF THE SEAL ON THE TUBE IS PUNCTURED OR NOT VISIBLE.
• store between 20º to 25ºC (68º to 77ºF)
• Lot No. & Expiration Date: see box or crimp of tube

Inactive Ingredients

Cetostearyl alcohol, chlorocresol, light mineral oil, monobasic sodium phosphate, polyoxyl 20 cetyl ether, propylene glycol, water, white petrolatum.

Questions or comments?

Call 1-844-474-7464

PRINCIPAL DISPLAY PANEL

Distributed by:
Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816
Made in India
Mfg. Lic. No.: G/25/1362
Issued: 12/2025

INGREDIENTS AND APPEARANCE

PEDIKLEER 
tolnaftate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57237-354
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
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CHLOROCRESOL (UNII: 36W53O7109)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57237-354-15	1 in 1 CARTON	12/16/2025
1		15 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 57237-354-30	1 in 1 CARTON	12/16/2025
2		30 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 Drug	M005	12/16/2025

Labeler - Rising Pharma Holdings, Inc. (116880195)

Registrant - Elysium Pharmaceuticals Ltd (915664486)

Establishment
Name	Address	ID/FEI	Business Operations
Elysium Pharmaceuticals Ltd		915664486	manufacture(57237-354) , analysis(57237-354) , pack(57237-354) , label(57237-354)