FIRST AID RESEARCH ANTIFUNGAL CREAM 1OZ- clotrimazole cream 
First Aid Research Corp.

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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Active ingredient                            Purpose

Clotrimazole 1%........................... Antifungal

Uses

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 the eyes

Stop use and ask a doctor if

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

Directions

Other information

Inactive ingredients

2-octyldodecanol, benzyl alcohol, cetearly alcohol, cetyl esters, monobasic sodium phosphate dihydrate, polysorbate 60, propylene glycol, purified water, sorbitan stearate

Distributed by:

First Aid Research Corp.

Wantagh, NY 11793 USA

Made in Korea

image description

FIRST AID RESEARCH ANTIFUNGAL CREAM 1OZ 
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75983-464
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CETYL ESTERS WAX (UNII: D072FFP9GU)  
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
PEG-60 SORBITAN STEARATE (UNII: 073G38N8GC)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75983-464-281 in 1 CARTON
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C10/14/2014
Labeler - First Aid Research Corp. (089405927)

Revised: 10/2014
Document Id: fca0c59d-8a8f-405b-80ab-d70a31ad7fab
Set id: ce93582d-ac8a-49e4-a8a5-b9f2b003fb29
Version: 1
Effective Time: 20141014
 
First Aid Research Corp.