FORMULA 7 THEGEL- tolnaftate gel

Formula 7 THEGEL by

Drug Labeling and Warnings

Formula 7 THEGEL by is a Otc medication manufactured, distributed, or labeled by The Tetra Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Uses:

Antifungal 

INDICATIONS & USAGE

For effective treatment of most athlete’s foot and ringworm.
Relieves:

Itching

Scaling

Cracking
Redness

Soreness

Burning

Irritation

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

Active ingredient

Tolnaftate 1%

Stop use and ask a doctor if:

When using for treatment of 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.

DO NOT USE SECTION

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

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding ask a health professional before use.

Questions or comments?

1-800-826-0479
9:00 AM to 5:30 PM EST.

Inactive Ingredients

Inactive Ingredients: Water (aqua),C12-15 Alkyl Benzoate, SimmondsiaChinensis (Jojoba) Oil, Glycerin,Oleth-10, Oleth-5, Oleth-3 Phosphate,PEG-20 Hydrogenated Lanolin,Butylene Glycol, Urea, Ethoxydiglycol,N-Acetyl-L-Cysteine, TocopherolAcetate (Vitamin E), Melaleuca
Alternifolia (Tea Tree) Oil, DisodiumEDTA, Ethylhexylglycerin, CaprylylGlycol, Phenoxyethanol, Aminomethylpropanediol,Sodium Chloride.

Directions:

For treatment of athlete’s foot and ringworm:

Clean 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, 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 the scalp or nails.

To prevent athlete’s foot:
Wash 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.

Other information

Store at room temperature, 25ºC (77ºF).

Warnings

For external use only.

When using this product avoid contact with eyes.

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.

Product Label

INGREDIENTS AND APPEARANCE

FORMULA 7 THEGEL 
tolnaftate gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49406-008
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
WATER (UNII: 059QF0KO0R)
JOJOBA OIL (UNII: 724GKU717M)
GLYCERIN (UNII: PDC6A3C0OX)
OLETH-10 (UNII: JD797EF70J)
OLETH-5 (UNII: 1GH33785AY)
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)
PEG-20 HYDROGENATED LANOLIN (UNII: 5PP3KJ4T6S)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
UREA (UNII: 8W8T17847W)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TEA TREE OIL (UNII: VIF565UC2G)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ACETYLCYSTEINE (UNII: WYQ7N0BPYC)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49406-008-30	15 g in 1 PACKAGE; Type 0: Not a Combination Product	06/13/2018
2	NDC: 49406-008-28	28 g in 1 JAR; Type 0: Not a Combination Product	01/28/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	06/13/2018

Labeler - The Tetra Corporation (829958409)

Registrant - The Tetra Corporation (829958409)