FOOTSHIELD PLUS- tolnaftate cream

footshield plus by

Drug Labeling and Warnings

footshield plus by is a Otc medication manufactured, distributed, or labeled by Q.A. Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

DOSAGE & ADMINISTRATION

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FOOTSHIELD PLUS  
tolnaftate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52099-7005
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)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52099-7005-1	142 g in 1 TUBE; Type 0: Not a Combination Product	02/01/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	02/01/2012

Labeler - Q.A. Laboratories (065361149)

Registrant - Q.A. Laboratories (065361149)

Establishment
Name	Address	ID/FEI	Business Operations
Q.A. Laboratories		065361149	manufacture(52099-7005)