SKINHEAL ANTIFUNGAL- tolnaftate cream

SKINHEAL ANTIFUNGAL by

Drug Labeling and Warnings

SKINHEAL ANTIFUNGAL by is a Otc medication manufactured, distributed, or labeled by Zhejiang Dingtai Pharmaceutical Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient
Tolnaftate 1.0%

PURPOSE

Purpose
Antifungal

INDICATIONS & USAGE

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

Warnings
For external use only

DO NOT USE

Do not use

on children under 2 years of age unless directed by a doctor

WHEN USING

When using this product

avoid contact with the eyes

STOP USE

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 right away.

DOSAGE & ADMINISTRATION

Directions
Adults and children 2 years of age or older:

   wash 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 spaces between the toes
      wear well-fitting, ventilated shoes

      change shoes and socks at least once daily
   use daily for 4 weeks for the treatment of athlete’s foot and ringworm
      if condition persists longer, consult a doctor
      use daily for the prevention of athlete’s foot

   this product is not effective on the scalp or nails
Children under 2 years: do not use unless directed by a doctor

STORAGE AND HANDLING

Other information
keep container tightly closed

store between 15 and 30 C (59 to 86 F)

INACTIVE INGREDIENT

Inactive ingredients  cetostearyl alcohol, glycerin, glyceryl monostearate, petrolatum, propylene glycol, sodium sulfite, steareth- 20, stearic acid, and water

QUESTIONS

Questions or comments? (888) 221-3496 M-F 9am-5pm
you may also report serious side effects to this phone number

PRINCIPAL DISPLAY PANEL

SKINHEAL ANTIFUNGAL CREAM
Tolnaftate 1%
Net Wt. 10 g (1/3 oz)
NDC: 69070-305-01

INGREDIENTS AND APPEARANCE

SKINHEAL ANTIFUNGAL 
tolnaftate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69070-305
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)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM SULFITE (UNII: VTK01UQK3G)
STEARETH-20 (UNII: L0Q8IK9E08)
STEARIC ACID (UNII: 4ELV7Z65AP)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69070-305-01	1 in 1 BOX	12/10/2018
1		10 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	12/10/2018

Labeler - Zhejiang Dingtai Pharmaceutical Co., Ltd (420598724)

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Dingtai Pharmaceutical Co., Ltd		420598724	manufacture(69070-305)