ANTIFUNGAL CREAM- antifungal cream

Antifungal Cream by

Drug Labeling and Warnings

Antifungal Cream by is a Otc medication manufactured, distributed, or labeled by BluePoint Laboratories, Gopaldas Visram & Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Clotrimazole 1 %

Purpose

Antifungal

Uses

• 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 or itching, burning feet.

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 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.

Keep Out Of Reach Of Children

if swallowed, get medical help or contact a Poison Control Center right away.

Directions

• 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.

DOSAGE & ADMINISTRATION

• For athletes 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

• Do not use if seal on the tube is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal
• Store at room temperature
• Preserve in tight containers
• See crimp of tube or carton for Lot Number and Expiry Date

INACTIVE INGREDIENTS

Inactive Ingredients: Cetostearyl Alcohol, Methylparaben, Mineral Oil, Polyoxyl 20 Cetostearyl Ether,

Propylene Glycol, Propylparaben, Purified water, White petrolatum

Questions?

Contact 1-800-707-4621

Manufactured in India by:

Gopaldas Visram & Company Limited,

Plot No. A327, T.T.C. Indl. Area, M.I.D.C.

Mahape, Navi Mumbai - 400710.

Mfg. Lic. No.: KD/739

For BluePoint Laboratories

Rev 09/2021

PRINCIPAL DISPLAY PANEL

Clotrimazole 1% 0.5oz 68001-475-45

Principal Display Panel

Clotrimazole 1% 1oz 68001-475-47

INGREDIENTS AND APPEARANCE

ANTIFUNGAL CREAM 
antifungal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68001-475
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
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
MINERAL OIL (UNII: T5L8T28FGP)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68001-475-47	1 in 1 CARTON	11/25/2020
1		28.4 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 68001-475-46	1 in 1 CARTON	11/25/2020	06/14/2021
2		15 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 68001-475-45	1 in 1 CARTON	11/25/2020
3		14.2 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	11/25/2020

Labeler - BluePoint Laboratories (985523874)

Establishment
Name	Address	ID/FEI	Business Operations
Gopaldas Visram & Co., Ltd		858030888	manufacture(68001-475)