Formula 7 The SOLUTION

Formula 7 The SOLUTION

Drug Labeling and Warnings

Drug Details

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FORMULA 7 - THE SOLUTION- tolnaftate solution 
The Tetra Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Formula 7 The SOLUTION

Uses:

Antifungal 

Indication 

For effective treatment of most athlete’s foot
(tinea pedis) and ringworm (tinea corporis).
Relieves:

Itching

Scaling

Cracking
Redness

Soreness

Burning

Irritation

Prevents the recurrence of most athlete’s foot 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 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 unles  as 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 ring worm.

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 (morningand/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

Storage

Store above 12ºC (55ºF).

Warnings

For external use only.

When using this product avoid contact with eyes.

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

Product Label

solution

FORMULA 7 - THE SOLUTION 
tolnaftate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 49406-007
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Tolnaftate (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) Tolnaftate1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 49406-007-1515 g in 1 PACKAGE; Type 0: Not a Combination Product06/13/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C06/13/2018
Labeler - The Tetra Corporation (829958409)
Registrant - The Tetra Corporation (829958409)
Establishment
NameAddressID/FEIBusiness Operations
Paket Corporation007774730manufacture(49406-007)

Revised: 6/2018
 
The Tetra Corporation


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