CLOTRIMAZOLE by ALLIED TRADE LINK LLC / GOLPALDAS VISRAM AND COMPANY LIMITED CLOTRIMAZOLE cream

CLOTRIMAZOLE by

Drug Labeling and Warnings

CLOTRIMAZOLE by is a Otc medication manufactured, distributed, or labeled by ALLIED TRADE LINK LLC, GOLPALDAS VISRAM AND COMPANY LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE AND ADMISITRATION

Clotrimazole 1% ..

Clean the affected area and dry thoroughly. Apply a thin layer of cream 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 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

Warnings

For External Use Only
Do not use On children under 2 years of age unless directed by a doctor For diaper rash.
When using this product Avoid contact with the eyes
Stop use and ask a doctor if Irritation occurs There is no improvement within 2 weeks when used for the treatment of jock itch There is no
improvement within 4 weeks when used for athlete’s foot or ringworm

INACTIVE INGREDIENT

Cetostearyl Alcohol, Methylparaben, Mineral Oil, Macrogol cetostearyl ether, Propylene Glycol, Propylparaben, Purified Water, White Petrolatum

INDICATIONS & USAGE

For the treatment of most athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
Relieves itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch and itching or burning feet

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

PURPOSE

Antifungal

WARNINGS

For External Use Only
Do not use On children under 2 years of age unless directed by a doctor For diaper rash.
When using this product Avoid contact with the eyes
Stop use and ask a doctor if Irritation occurs There is no improvement within 2 weeks when used for the treatment of jock itch There is no
improvement within 4 weeks when used for athlete’s foot or ringworm

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CLOTRIMAZOLE 
clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84387-004
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
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
MINERAL OIL (UNII: T5L8T28FGP)
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84387-004-01	28.4 g in 1 TUBE; Type 0: Not a Combination Product	11/08/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	11/08/2024

Labeler - ALLIED TRADE LINK LLC (029033682)

Registrant - ALLIED TRADE LINK LLC (029033682)

Establishment
Name	Address	ID/FEI	Business Operations
GOLPALDAS VISRAM AND COMPANY LIMITED		858030888	manufacture(84387-004)