CLOTRIMAZOLE by Kinray Inc. / Dynarex Corporation / Blossom Pharmaceuticals CLOTRIMAZOLE cream

CLOTRIMAZOLE by

Drug Labeling and Warnings

CLOTRIMAZOLE by is a Otc medication manufactured, distributed, or labeled by Kinray Inc., Dynarex Corporation, Blossom Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Purpose

• For treatment of most athlete's foot (tinea pedis), jock itch (tinea crusis), Ringworm (tinea corporis).
• For the treatment of superficial skin infections caused by Yeast (Candida Albicans).
• Relieves itching, scaling, cracking, burning, redness, soreness, irritation discomfort and chafing associated with jock itch.
  

Active Ingredient

Active Ingredient                         Purpose

Clotrimazole 1.0%                      Antifungal

Warnings

Do not use:

• Do not use on children under 2 years of age unless directed by a doctor.
• Avoid contact with eyes.
• For athletes foot and ringworm - if irritation occurs, or if there is no improvement within 4 weeks, discontinue use and consult a doctor.
• For jock itch - if irritation occurs, or if there is no improvement within two weeks, discontinue use and consult a doctor.
• Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
  

Indications & Usage

• Supervise children in the use of this product.
• If conditions persist longer, consult a doctor.
• This product is not effective on scalp or nails.
  

Other information.

Protect from freezing. Avoid excessive heat.

Dosage & Administration

• Clean the affected area and dry thoroughly. Apply a layer of cream over affected area twice daily (morning and night) or as directed by a doctor.
• Foe athlete's foot and ringworm, use daily for 4 weeks.
• For jock itch, use daily for 2 weeks.
• 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.

Inactive Ingredients

Inactive Ingredients: Cetomacrogol 1000, cetostearyl alcohol, liquid paraffin, methylparaben, propylene glycol, propylparaben, purified water, white soft paraffin.

Keep Out of Reach of Children

• KEEP OUT OF REACH OF CHILDREN
• If swallowed get medical help or contact a Poison Control Center.
  

Principal Display Panel

Kinray Antifungal

KR_Antifungal.jpg

INGREDIENTS AND APPEARANCE

CLOTRIMAZOLE 
clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63777-231
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
CETETH-20 (UNII: I835H2IHHX)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63777-231-01	28.4 g in 1 TUBE; Type 0: Not a Combination Product	01/11/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	01/11/2012

Labeler - Kinray Inc. (012574513)

Registrant - Dynarex Corporation (008124539)

Establishment
Name	Address	ID/FEI	Business Operations
Blossom Pharmaceuticals		677381470	manufacture(63777-231)