Label: CLOTRIMAZOL cream
CLOTRIMAZOL DUAL cream
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Contains inactivated NDC Code(s)
NDC Code(s): 73519-003-01, 73519-004-01 - Packager: Laboratorios Química Son's, S.A. de C.V.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated January 11, 2022
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- Official Label (Printer Friendly)
- INACTIVE INGREDIENT
- ACTIVE INGREDIENT
- ASK DOCTOR
- DO NOT USE
- KEEP OUT OF REACH OF CHILDREN
- PREGNANCY OR BREAST FEEDING
- PURPOSE
- QUESTIONS
- WHEN USING
- STOP USE
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- WARNINGS
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CLOTRIMAZOL
clotrimazol creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73519-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE 0.2 g in 1 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:73519-003-01 3 g in 1 TUBE; Type 0: Not a Combination Product 03/16/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 03/15/2022 CLOTRIMAZOL DUAL
clotrimazol dual creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73519-004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE 1 g in 1 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:73519-004-01 1 g in 1 TUBE; Type 0: Not a Combination Product 03/15/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 03/15/2022 Labeler - Laboratorios Química Son's, S.A. de C.V. (815603378) Establishment Name Address ID/FEI Business Operations Laboratorios Química Son's, S.A. de C.V. 821298692 manufacture(73519-003, 73519-004)
