CLOTRIMAZOLE CREAM 1% cream

Clotrimazole Cream 1% by

Drug Labeling and Warnings

Clotrimazole Cream 1% by is a Otc medication manufactured, distributed, or labeled by SOLA Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Clotrimazole 1%

Purpose

Antifungal

Usage

• For External treatment of most athlete's foot (tinea pedis), jock ithc (tinea crusis), ringworm (tinea corporis).
• Relieves itching, cracking scaling irritation and chafing associated with these conditions.

Warnings

Do not use on children under 2 years of age unless directed by a doctor.

For external use only.

Avoid contact with eyes.

If irritation occurs or if there is no improvement within 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch), discontinue use and consult a doctor.

Keep this and all drugs out of the reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN

Keep this and all drugs our of the reach of children. In case of accidental ingestion, seek profesional assistance or contact a Poison Control Center right away.

Directions

• Clean the affected area and dry thoroughly. Apply a layer of cream over the affected area twice daily morning and night or as directed by doctor.
• Supervise children in the use of this product.
• For athlete's foot pay special attention to the spaces between toes. Wear well fitting ventilated shoes and change shoes and 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 persist longer consult a doctor.
• This product is not effective on scalp or nails.

Inactive Ingredients

Cetomacragol 1000, Cetostearyl alcohol, Liquid paraffin, Methyl Paraben, Propyl paraben, Propylene glycol, Purified water, White soft paraffin.

Other Information

• Store between 20ºC and 25ºC (68ºF and 77ºF)

Questions or comments?

Call 1-866-747-7365

Package Display Panel

Questions or comments?

Call 1-866-747-7365

Manufactured for : SOLA Pharmaceuticals

Baton Rouge, LA 70810

Store in a dry, cool place

For Comments or Questions, call 866-747-7365

Clotrimazole 1% Cream

NDC: 70512-100-30

Qty: 28.4g

INGREDIENTS AND APPEARANCE

CLOTRIMAZOLE CREAM 1% 
clotrimazole cream 1% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70512-100
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
PETROLATUM (UNII: 4T6H12BN9U)
MINERAL OIL (UNII: T5L8T28FGP)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
CETETH-20 (UNII: I835H2IHHX)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
METHYLPARABEN (UNII: A2I8C7HI9T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70512-100-30	1 in 1 CARTON	04/14/2020
1		30 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	04/14/2020

Labeler - SOLA Pharmaceuticals (080121345)