TM-CLOTRIMAZOLE- clotrimazole 1% cream

TM-Clotrimazole by

Drug Labeling and Warnings

TM-Clotrimazole by is a Otc medication manufactured, distributed, or labeled by Singular Dreamer, Ltd dba True Marker. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Clotrimazole USP 1% w/w

Purpose

Antifungal

Uses

• Cures athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis).
• Relieves the itching, irritation, redness, scaling and discomfort which can 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 within 2 weeks (for jock itch).
• Keep out of 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

Directions

• Wash the 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 the spaces between the 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 persists longer, consult a doctor.
• This product is not effective on the scalp or nails.

Other information

• Store at controlled room temperature 15° - 30°C (59° - 86°F)
• Close cap tightly after use.

Inactive ingredients

Alcohol, Butylated hydroxytoluene, Cetostearyl alcohol, Dimethyl sulfoxide, Edetate disodium, Ethylparaben, Glycerol, Mineral oil, Mono-and di-glycerides,Petrolatum, Polyoxyethylene lauryl ether, Purified water.

Questions?

304-742-2433

Product label

INGREDIENTS AND APPEARANCE

TM-CLOTRIMAZOLE 
clotrimazole 1% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83035-1062
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
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALCOHOL (UNII: 3K9958V90M)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIMETHYL SULFOXIDE (UNII: YOW8V9698H)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLPARABEN (UNII: 14255EXE39)
GLYCERIN (UNII: PDC6A3C0OX)
MINERAL OIL (UNII: T5L8T28FGP)
GLYCERYL MONO AND DIPALMITOSTEARATE (UNII: KC98RO82HJ)
PETROLATUM (UNII: 4T6H12BN9U)
GLYCERETH-31 (UNII: 11L9WC241B)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83035-1062-3	1 in 1 CARTON	04/03/2023
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 Drug	M005	04/03/2023

Labeler - Singular Dreamer, Ltd dba True Marker (129504103)

Registrant - Singular Dreamer, Ltd dba True Marker (129504103)