Clotrimazole by Kareway Product, Inc. CLOTRIMAZOLE cream

Clotrimazole by

Drug Labeling and Warnings

Clotrimazole by is a Otc medication manufactured, distributed, or labeled by Kareway Product, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

For external use only

When using this product

avoid contact with the eyes

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

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• wash affected area and dry thoroughly
• apply a thin layer cover 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
  

Other information

• store between 2°and 30° C (36° and 86° F)

Inactive ingredients

butylated hydroxytoluene, carbomer 940, cetyl alcohol, ethylparaben, glycerin, glyceryl stearate, propylene glycol, sodium lauryl sulfate, stearic acid, water

PRINCIPAL DISPLAY PANEL

Clotrimazole

INGREDIENTS AND APPEARANCE

CLOTRIMAZOLE 
clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67510-0638
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)	CLOTRIMAZOLE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
GLYCERYL 1-STEARATE (UNII: 258491E1RZ)
CARBOMER 940 (UNII: 4Q93RCW27E)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ETHYLPARABEN (UNII: 14255EXE39)
STEARIC ACID (UNII: 4ELV7Z65AP)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67510-0638-1	1 in 1 BOX	08/27/2018
1		28 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	08/11/2011

Labeler - Kareway Product, Inc. (121840057)