FOOTSHIELD PLUS - tolnaftate cream 
Q.A. Laboratories

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

impage of carton label

FOOTSHIELD PLUS  
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52099-7005
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)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
UREA (UNII: 8W8T17847W)  
GLYCERIN (UNII: PDC6A3C0OX)  
LANOLIN OIL (UNII: OVV5IIJ58F)  
EGG WHITE (UNII: 3E0I92Z2GR)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
TEA TREE OIL (UNII: VIF565UC2G)  
MINERAL OIL (UNII: T5L8T28FGP)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ALLANTOIN (UNII: 344S277G0Z)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
DEXPANTHENOL (UNII: 1O6C93RI7Z)  
VITAMIN A (UNII: 81G40H8B0T)  
VITAMIN D (UNII: 9VU1KI44GP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52099-7005-1142 g in 1 TUBE; Type 0: Not a Combination Product02/01/201212/31/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C02/01/201212/31/2016
Labeler - Q.A. Laboratories (065361149)
Registrant - Q.A. Laboratories (065361149)
Establishment
NameAddressID/FEIBusiness Operations
Q.A. Laboratories065361149manufacture(52099-7005)

Revised: 1/2022
 
Q.A. Laboratories