HEALTHY ACCENTS ANTIFUNGAL- clotrimazole cream 
DZA Brands LLC

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 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 right away

Directions

Other information store between 20° to 25° (68° to 77°F)

Inactive ingredients

benzyl alcohol, cetanol, liquid paraffin, octyldodecanol, polysorbate 60, propylene glycol, purified water, sodium hydroxide, sorbitan monostearate, stearic acid, stearyl alcohol

Distributed by:

Salisbury, NC 28147

Scarborough, ME 04074

Product of Korea

image description

HEALTHY ACCENTS ANTIFUNGAL 
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55316-829
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE10 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
PARAFFIN (UNII: I9O0E3H2ZE)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55316-829-281 in 1 CARTON08/03/2016
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C07/26/2016
Labeler - DZA Brands LLC (090322194)

Revised: 8/2016
Document Id: 3062db68-4378-4332-ab50-9c7e1414aa72
Set id: 52f28770-c455-4c04-a7c1-a7e6a3c3d9c5
Version: 1
Effective Time: 20160803
 
DZA Brands LLC