Clotrimazole by LIFElabs, a Division of Atico International USA, INC. CLOTRIMAZOLE cream

Clotrimazole by

Drug Labeling and Warnings

Clotrimazole by is a Otc medication manufactured, distributed, or labeled by LIFElabs, a Division of Atico International USA, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Clotrimazole

Active Ingredient

Clotrimazole 1%

PURPOSE

Purpose

Antifungal

Uses

• cures most athlete's foot, jock itch, and ringworm
• relieves itching, burning, cracking, scaling and discomfort which accompany these conditions
  

WARNINGS

Warnings

Do not use on children under 2 years of age except under the advice and supervision of a doctor.

For external use only.

INDICATIONS & USAGE

When using this product avoid contact with the eyes.

STOP USE

Stop use and ask a doctor if

• irritation occurs
• there is no improvement within 4 weeks (for athlete's foot and ringworm) or 2 weeks (for jock itch)
• do not use for diaper rash
  

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Directions

• wash affected area and dry thoroughly
• apply a thin layer 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 and change shoes and socks at least once a day
• for athlete's foot and ringworm use daily for 4 weeks, for jock itch use daily for 2 weeks
• if conditions persist longer, ask a doctor
• this product is not effective on the scalp or nails
  

STORAGE AND HANDLING

Other information

store between 2o and 30o C (30o and 86o F) Lot No. and Exp. Date: see box or see crimp of tube

INACTIVE INGREDIENT

Inactive ingredients

benzyl alcohol, isopropyl myristate, liquid parafin, polysorbate 60, propylene glycol, purified water, stearic acid, stearyl aclohol, sorbitan monostearate

QUESTIONS

Questions?

Call 1-800-645-3867, Mon-Fri 8:30 AM - 5:30 PM.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CLOTRIMAZOLE 
clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51852-103
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)
Isopropyl Myristate (UNII: 0RE8K4LNJS)
Mineral Oil (UNII: T5L8T28FGP)
Polysorbate 60 (UNII: CAL22UVI4M)
Propylene Glycol (UNII: 6DC9Q167V3)
Water (UNII: 059QF0KO0R)
Stearic Acid (UNII: 4ELV7Z65AP)
Stearyl Alcohol (UNII: 2KR89I4H1Y)
Sorbitan Monostearate (UNII: NVZ4I0H58X)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51852-103-01	1 in 1 BOX
1		28 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	11/01/2010

Labeler - LIFElabs, a Division of Atico International USA, INC. (073876450)