ANTIFUNGAL CREAM- antifungal cream 
BluePoint Laboratories

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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 finalpart333C11/25/2020
Labeler - BluePoint Laboratories (985523874)
Establishment
NameAddressID/FEIBusiness Operations
Gopaldas Visram & Co., Ltd858030888manufacture(68001-475)

Revised: 10/2021
Document Id: ce3b8cef-7e0f-bb80-e053-2a95a90afae3
Set id: b4c4240f-f84c-ec5e-e053-2a95a90aa082
Version: 4
Effective Time: 20211013
 
BluePoint Laboratories