HEB ANTIFUNGAL- clotrimazole cream

HEB by

Drug Labeling and Warnings

HEB by is a Otc medication manufactured, distributed, or labeled by H E B, 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, jock itch and ringworm
• relieves itching, burning, cracking, scaling and discomfort which accompany these conditions

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 a doctor if

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

• wash 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 the toes, wear well-fitting, ventilated shoes and change socks at least once daily
• for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
• if condition persists longer, ask a doctor
• this product is not effective on the scalp or nails

Other information

• To open: unscrew cap, use the pointed end of cap to puncture seal.
• store between 20° - 25°C (68° - 77°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

Questions?

Call 1-866-923-4914

PRINCIPAL DISPLAY PANEL - 14.2 g Tube Carton

Compare to Lotrimin® AF* active ingredient

NDC: 37808-305-01

H-E-B®
Athlete's Foot Cream
Clotrimazole Cream USP, 1%
Antifungal

Cures Most
Athlete's Foot

Relieves Itching, Burning, Cracking and Scaling
NET WT. 0.5 OZ (14.2g)

INGREDIENTS AND APPEARANCE

HEB   ANTIFUNGAL
clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37808-305
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: 37808-305-01	1 in 1 CARTON	08/31/1993
1		14.2 g in 1 TUBE; Type 0: Not a Combination Product

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

Labeler - H E B (007924756)

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

Establishment
Name	Address	ID/FEI	Business Operations
Taro Pharmaceuticals Inc.		206263295	MANUFACTURE(37808-305)