THERA PLUS ANTIFUNGAL CLOTRIMAZOLE- clotrimazole cream

Thera plus Antifungal Clotrimazole by

Drug Labeling and Warnings

Thera plus Antifungal Clotrimazole by is a Otc medication manufactured, distributed, or labeled by FOURSTAR GROUP USA, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Clotrimazole 1% w/w

Purpose

Antifungal

Uses

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

Warnings

For external use only.

Do not use

• on children under 2 years of age except under the advice of 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).

If pregnant or breast-feeding,

ask a health professional before use

Keep this and all drugs out of the reach of children.

if swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

• wash the affected area and dry thoroughly.
• apply a thin layer over affected area twice daily (morning and night)
• 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 conditions persists longer, consult a doctor.
• This product is not effective on the scalp or nails.

Other information

• store at room temperature 20°-25°C (68°-77°F).
• close cap tightly after use.

Inactive ingredients

cetostearyl alcohol, ethylparaben, glycerin, glyceryl monostearate, mineral oil, peregal O-25, petrolatum, purified water, stearic acid

Questions or comments?

Call 1-888-296-9067 Mon-Fri 9 AM-5 PM

Package Labeling:

INGREDIENTS AND APPEARANCE

THERA PLUS ANTIFUNGAL CLOTRIMAZOLE 
clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80684-039
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
LAURETH-23 (UNII: N72LMW566G)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ETHYLPARABEN (UNII: 14255EXE39)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80684-039-01	1 in 1 BOX	01/30/2022
1		14 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	01/30/2022

Labeler - FOURSTAR GROUP USA, INC. (140099503)