FORMULA 3- tolnaftate solution

Formula 3 by

Drug Labeling and Warnings

Formula 3 by is a Otc medication manufactured, distributed, or labeled by Canadian Custom Packaging Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

FORMULA 3

Active ingredient:

Tolnaftate 1%

Purpose

Antifungal

Uses:

For effective treatment of most athlete's foot and ringworm.

Relieves:

• Itching
• Soreness
• Scaling
• Burning
• Cracking
• Irritation
• Redness

Prevents the recurrence of most athlete's foot (dermatophytosis) with daily use.

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 eyes.

Stop use and ask a doctor if

• When using for athlete's foot or ringworm: If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor.
• When using for the prevention of athlete's foot: If irritation occurs,discontinue use and consult a doctor.

If pregnant or breastfeeding ask a health professional before use.

Keep out of reach of children.

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

Directions

For treatment of athlete's foot and ringworm

• 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.
• 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.
• For athlete's foot and ringworm, use daily for 4 weeks.
  
• If condition persists longer, consult a doctor. This product is not effective on scalp or nail.

To prevent athlete's foot:

• Clean the feet and dry thoroughly.
• Apply a thin layer of the product to the feet once or twice daily (morning and/or 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.

Inactive ingredients

Apricot Kernel Oil, Rice Bran Oil, Sesame Seed Oil, Safflower Oil, Jojoba Oil, Vitamin E Acetate, Methyl Paraben, Propyl Paraben and Butyl Paraben.

FORMULA 3 BRAND Antifungal Tolnaftate 1% Antifungal Solution 15ml (49406-003-15)

Representative Labeling

INGREDIENTS AND APPEARANCE

FORMULA 3 
tolnaftate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54291-036
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
APRICOT KERNEL OIL (UNII: 54JB35T06A)
RICE BRAN OIL (UNII: LZO6K1506A)
SESAME OIL (UNII: QX10HYY4QV)
SAFFLOWER OIL (UNII: 65UEH262IS)
JOJOBA OIL (UNII: 724GKU717M)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
BUTYLPARABEN (UNII: 3QPI1U3FV8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54291-036-01	1 in 1 BOX	10/30/2012
1		15 mL in 1 BOTTLE; 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	10/30/2012

Labeler - Canadian Custom Packaging Company (207062514)

Registrant - Canadian Custom Packaging Company (207062514)

Establishment
Name	Address	ID/FEI	Business Operations
Canadian Custom Packaging Company		207062514	manufacture(54291-036)