ANTIFUNGAL CREAM- antifungal cream 
BluePoint Laboratories

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1 % Clotrimazole Cream, USP

Drug Facts

Active ingredient

Clotrimazole 1 %

Purpose

Antifungal

Uses

Warnings

For external use only

Do not use:

When using this product

Stop use and ask a doctor if

Keep Out Of Reach Of Children

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

Directions

Other Information

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

Clotrimazole 1% 0.5oz 68001-475-45

0.5 tube0.5 carton

Principal Display Panel

1 oz carton Clotrimazole 1% 1oz 68001-475-47

1 oz tube

ANTIFUNGAL CREAM 
antifungal cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68001-475
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68001-475-471 in 1 CARTON11/25/2020
128.4 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:68001-475-461 in 1 CARTON11/25/202006/14/2021
215 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:68001-475-451 in 1 CARTON11/25/2020
314.2 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00511/25/2020
Labeler - BluePoint Laboratories (985523874)
Establishment
NameAddressID/FEIBusiness Operations
Gopaldas Visram & Co., Ltd858030888manufacture(68001-475)

Revised: 11/2023
Document Id: 097d120f-44a3-3b38-e063-6294a90a8e70
Set id: b4c4240f-f84c-ec5e-e053-2a95a90aa082
Version: 5
Effective Time: 20231117
 
BluePoint Laboratories