footshield plus

Dosage form: cream
Ingredients: Tolnaftate 1g in 100g
Labeler: Q.A. Laboratories
NDC Code: 52099-7005

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.

Footshield Plus

Active Ingredient Purpose

Tolnaftate 1%........................Antifungal

Uses

Proven clinically to cure most:
athlete’s foot (tinea pedis) ■ ringworm
(tinia corporis). Effectively soothes and
relieves: itching ■ burning ■ cracking ■
helps prevent most athlete’s foot from
coming back with daily use.

Keep out of reach of children.

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

Directions

Clean the affected area and dry
thoroughly ■ apply a thin layer over affected area
twice daily (morning and night). Supervise children
in the use of this product ■ for athlete’s foot, pay
special attention to spaces between toes. Wear
well-fitting, ventilated shoes, and change shoes
and socks at least once daily. ■ use daily for 4
weeks. If condition lasts longer, ask a doctor ■ to
prevent athlete’s foot, apply to the feet once or
twice daily (morning and night) ■ this product is
not effective on scalp and nails

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 doctor if: irritation occurs ■ there
is no improvement within 4 weeksFor external use only

apply a thin layer over affected area
twice daily (morning and night)

Inactive ingredients

Deionized water,
cetearyl alcohol, urea, glycerin, lanolin oil,
albumen, ceteareth-20, dimethicone, isopropyl
myristate, tea tree oil, mineral oil, aloe vera,
phenoxyethanol, allantoin, vitamin E, dexapanthenol,
vitamin A, vitamin D, methyl and propyl paraben


FOOTSHIELD PLUS  
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52099-7005
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Tolnaftate (TOLNAFTATE ) Tolnaftate1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER  
CETOSTEARYL ALCOHOL  
UREA 
GLYCERIN 
LANOLIN OIL  
EGG WHITE 
POLYOXYL 20 CETOSTEARYL ETHER  
DIMETHICONE 
ISOPROPYL MYRISTATE 
TEA TREE OIL 
MINERAL OIL 
ALOE VERA LEAF  
PHENOXYETHANOL 
ALLANTOIN 
ALPHA-TOCOPHEROL ACETATE  
DEXPANTHENOL 
VITAMIN A 
VITAMIN D 
METHYLPARABEN 
PROPYLPARABEN 
Packaging
#Item CodePackage Description
1NDC:52099-7005-1142 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C02/01/2012
Labeler - Q.A. Laboratories (065361149)
Registrant - Q.A. Laboratories (065361149)
Establishment
NameAddressID/FEIOperations
Q.A. Laboratories065361149manufacture

Revised: 03/2012
 
Q.A. Laboratories

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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