PUBLIX ATHLETIC FOOT- clotrimazole cream

Publix by

Drug Labeling and Warnings

Publix by is a Otc medication manufactured, distributed, or labeled by Publix Super Markets Inc, Taro Pharmaceuticals U.S.A., Inc., Taro Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Clotrimazole 1%

Purpose

Antifungal

Uses

• cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)
• for effective relief of
  • itching
  • scaling
  • cracking
  • burning
  • redness
  • soreness
  • irritation
  • discomfort

Warnings

For external use only

Ask a doctor before use

• on children under 2 years of age

When using this product

• avoid contact with eyes

Stop use and ask a doctor if

• irritation occurs
• there is no improvement within 4 weeks (for athlete's foot and ringworm) or within 2 weeks (for jock itch)

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

Directions

This product is not effective on the scalp or nails.

For athlete's foot and ringworm: use daily for 4 weeks. For jock itch: use daily for 2 weeks.

• clean the affected area and dry thoroughly
• apply a thin layer of the product over 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; change shoes and socks at least once daily

Other information

• To open: unscrew cap, use the pointed end of cap to puncture seal.
• store between 2° - 30°C (36° - 86°F)
• see carton or tube crimp for lot number and expiration date

Inactive ingredients

benzyl alcohol (1%), cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sorbitan monostearate

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DISTRIBUTED BY PUBLIX
SUPER MARKETS, INC.
3300 PUBLIX CORPORATE PARKWAY
LAKELAND, FL 33811

PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

Publix
athleticfootcream
CLOTRIMAZOLE CREAM USP, 1%
ANTIFUNGAL CREAM

CURES MOST ATHLETE'S FOOT

NET WT 1 OZ (30 g)

INGREDIENTS AND APPEARANCE

PUBLIX   ATHLETIC FOOT
clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41415-056
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Clotrimazole (UNII: G07GZ97H65) (Clotrimazole - UNII:G07GZ97H65)	Clotrimazole	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
benzyl alcohol (UNII: LKG8494WBH)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetyl esters wax (UNII: D072FFP9GU)
octyldodecanol (UNII: 461N1O614Y)
polysorbate 60 (UNII: CAL22UVI4M)
water (UNII: 059QF0KO0R)
sorbitan monostearate (UNII: NVZ4I0H58X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41415-056-75	1 in 1 CARTON
1		30 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	08/31/1993

Labeler - Publix Super Markets Inc (006922009)

Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)

Establishment
Name	Address	ID/FEI	Business Operations
Taro Pharmaceuticals Inc.		206263295	MANUFACTURE(41415-056)