CLOTRIMAZOL- clotrimazol cream 
CLOTRIMAZOL DUAL- clotrimazol dual cream 
Laboratorios Química Son's, S.A. de C.V.

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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CLOTRIMAZOL

INACTIVE INGREDIENT

cream

prin

CLOTRIMAZOL 
clotrimazol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73519-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE0.2 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
PEG-20 SORBITAN STEARATE (UNII: HD40WR33LC) 0.2 g  in 1 g
POLYSORBATE 80 (UNII: 6OZP39ZG8H) 0.1 g  in 1 g
SODIUM BISULFITE (UNII: TZX5469Z6I) 0.2 g  in 1 g
METHYLPARABEN (UNII: A2I8C7HI9T) 0.0167 g  in 1 g
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 1 g  in 1 g
POLYSORBATE 60 (UNII: CAL22UVI4M) 0.15 g  in 1 g
PEG-25 PROPYLENE GLYCOL STEARATE (UNII: X21KPH4633) 0.2 g  in 1 g
WATER (UNII: 059QF0KO0R) 1 g  in 1 g
STEARYL ALCOHOL (UNII: 2KR89I4H1Y) 0.75 g  in 1 g
CETYL ALCOHOL (UNII: 936JST6JCN) 0.2 g  in 1 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73519-003-013 g in 1 TUBE; Type 0: Not a Combination Product03/16/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C03/15/2022
CLOTRIMAZOL DUAL 
clotrimazol dual cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73519-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE1 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
PEG-20 SORBITAN STEARATE (UNII: HD40WR33LC) 0.2 g  in 1 g
POLYSORBATE 80 (UNII: 6OZP39ZG8H) 0.1 g  in 1 g
SODIUM BISULFITE (UNII: TZX5469Z6I) 0.2 g  in 1 g
METHYLPARABEN (UNII: A2I8C7HI9T) 0.0167 g  in 1 g
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 1 g  in 1 g
POLYSORBATE 60 (UNII: CAL22UVI4M) 0.15 g  in 1 g
PEG-25 PROPYLENE GLYCOL STEARATE (UNII: X21KPH4633) 0.2 g  in 1 g
WATER (UNII: 059QF0KO0R) 1 g  in 1 g
STEARYL ALCOHOL (UNII: 2KR89I4H1Y) 0.75 g  in 1 g
CETYL ALCOHOL (UNII: 936JST6JCN) 0.2 g  in 1 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73519-004-011 g in 1 TUBE; Type 0: Not a Combination Product03/15/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C03/15/2022
Labeler - Laboratorios Química Son's, S.A. de C.V. (815603378)
Establishment
NameAddressID/FEIBusiness Operations
Laboratorios Química Son's, S.A. de C.V.821298692manufacture(73519-003, 73519-004)

Revised: 1/2022
Document Id: d5551abf-4d2b-35d2-e053-2a95a90a2782
Set id: d5551abf-4d2a-35d2-e053-2a95a90a2782
Version: 2
Effective Time: 20220111
 
Laboratorios Química Son's, S.A. de C.V.