Label: MITCHUM CLEAR GEL- aluminum sesquichlorohydrate liquid
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NDC Code(s):
10967-603-22,
10967-603-34,
10967-604-22,
10967-604-34, view more10967-604-70, 10967-605-22, 10967-605-34, 10967-607-22, 10967-607-34, 10967-608-22, 10967-608-34, 10967-611-34, 10967-612-22, 10967-612-34, 10967-647-34, 10967-648-34
- Packager: Revlon Consumer Products Corp
- 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 November 11, 2019
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- ACTIVE INGREDIENT
- Purpose
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- INACTIVE INGREDIENT
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MITCHUM CLEAR GEL
aluminum sesquichlorohydrate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10967-603 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALUMINUM SESQUICHLOROHYDRATE (UNII: UCN889409V) (ALUMINUM SESQUICHLOROHYDRATE - UNII:UCN889409V) ALUMINUM SESQUICHLOROHYDRATE 0.25 g in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCERIN (UNII: PDC6A3C0OX) PEG-12 DIMETHICONE (UNII: ZEL54N6W95) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) DIPROPYLENE GLYCOL (UNII: E107L85C40) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) LINALOOL, (+/-)- (UNII: D81QY6I88E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10967-603-34 100 mL in 1 CONTAINER; Type 0: Not a Combination Product 01/01/2014 2 NDC:10967-603-22 66 mL in 1 CONTAINER; Type 0: Not a Combination Product 01/01/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part350 01/01/2014 MITCHUM CLEAR GEL
aluminum sesquichlorohydrate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10967-611 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALUMINUM SESQUICHLOROHYDRATE (UNII: UCN889409V) (ALUMINUM SESQUICHLOROHYDRATE - UNII:UCN889409V) ALUMINUM SESQUICHLOROHYDRATE 0.25 g in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCERIN (UNII: PDC6A3C0OX) PEG-12 DIMETHICONE (UNII: ZEL54N6W95) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) DIPROPYLENE GLYCOL (UNII: E107L85C40) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) LINALOOL, (+/-)- (UNII: D81QY6I88E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10967-611-34 100 mL in 1 CONTAINER; Type 0: Not a Combination Product 01/01/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part350 01/01/2014 MITCHUM CLEAR GEL
aluminum sesquichlorohydrate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10967-647 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALUMINUM SESQUICHLOROHYDRATE (UNII: UCN889409V) (ALUMINUM SESQUICHLOROHYDRATE - UNII:UCN889409V) ALUMINUM SESQUICHLOROHYDRATE 0.25 g in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCERIN (UNII: PDC6A3C0OX) PEG-12 DIMETHICONE (UNII: ZEL54N6W95) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) DIPROPYLENE GLYCOL (UNII: E107L85C40) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) LINALOOL, (+/-)- (UNII: D81QY6I88E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10967-647-34 100 mL in 1 CONTAINER; Type 0: Not a Combination Product 01/01/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part350 01/01/2014 MITCHUM CLEAR GEL
aluminum sesquichlorohydrate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10967-648 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALUMINUM SESQUICHLOROHYDRATE (UNII: UCN889409V) (ALUMINUM SESQUICHLOROHYDRATE - UNII:UCN889409V) ALUMINUM SESQUICHLOROHYDRATE 0.25 g in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCERIN (UNII: PDC6A3C0OX) PEG-12 DIMETHICONE (UNII: ZEL54N6W95) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) DIPROPYLENE GLYCOL (UNII: E107L85C40) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) LINALOOL, (+/-)- (UNII: D81QY6I88E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10967-648-34 100 mL in 1 CONTAINER; Type 0: Not a Combination Product 01/01/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part350 01/01/2014 MITCHUM CLEAR GEL
aluminum sesquichlorohydrate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10967-604 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALUMINUM SESQUICHLOROHYDRATE (UNII: UCN889409V) (ALUMINUM SESQUICHLOROHYDRATE - UNII:UCN889409V) ALUMINUM SESQUICHLOROHYDRATE 0.25 g in 1 mL Inactive Ingredients Ingredient Name Strength .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) LINALOOL, (+/-)- (UNII: D81QY6I88E) WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCERIN (UNII: PDC6A3C0OX) PEG-12 DIMETHICONE (UNII: ZEL54N6W95) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) DIPROPYLENE GLYCOL (UNII: E107L85C40) Product Characteristics Color Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10967-604-34 100 mL in 1 CONTAINER; Type 0: Not a Combination Product 01/01/2014 2 NDC:10967-604-22 66 mL in 1 CONTAINER; Type 0: Not a Combination Product 01/01/2014 3 NDC:10967-604-70 20 mL in 1 CONTAINER; Type 0: Not a Combination Product 01/01/2014 
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part350 01/01/2014 MITCHUM CLEAR GEL
aluminum sesquichlorohydrate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10967-605 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALUMINUM SESQUICHLOROHYDRATE (UNII: UCN889409V) (ALUMINUM SESQUICHLOROHYDRATE - UNII:UCN889409V) ALUMINUM SESQUICHLOROHYDRATE 0.25 g in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCERIN (UNII: PDC6A3C0OX) PEG-12 DIMETHICONE (UNII: ZEL54N6W95) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) DIPROPYLENE GLYCOL (UNII: E107L85C40) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) LINALOOL, (+/-)- (UNII: D81QY6I88E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10967-605-34 100 mL in 1 CONTAINER; Type 0: Not a Combination Product 01/01/2014 2 NDC:10967-605-22 66 mL in 1 CONTAINER; Type 0: Not a Combination Product 01/01/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part350 01/01/2014 MITCHUM CLEAR GEL
aluminum sesquichlorohydrate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10967-607 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALUMINUM SESQUICHLOROHYDRATE (UNII: UCN889409V) (ALUMINUM SESQUICHLOROHYDRATE - UNII:UCN889409V) ALUMINUM SESQUICHLOROHYDRATE 0.25 g in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCERIN (UNII: PDC6A3C0OX) PEG-12 DIMETHICONE (UNII: ZEL54N6W95) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) DIPROPYLENE GLYCOL (UNII: E107L85C40) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) LINALOOL, (+/-)- (UNII: D81QY6I88E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10967-607-34 100 mL in 1 CONTAINER; Type 0: Not a Combination Product 01/01/2014 2 NDC:10967-607-22 66 mL in 1 CONTAINER; Type 0: Not a Combination Product 01/01/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part350 01/01/2014 MITCHUM CLEAR GEL
aluminum sesquichlorohydrate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10967-608 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALUMINUM SESQUICHLOROHYDRATE (UNII: UCN889409V) (ALUMINUM SESQUICHLOROHYDRATE - UNII:UCN889409V) ALUMINUM SESQUICHLOROHYDRATE 0.25 g in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCERIN (UNII: PDC6A3C0OX) PEG-12 DIMETHICONE (UNII: ZEL54N6W95) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) DIPROPYLENE GLYCOL (UNII: E107L85C40) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) LINALOOL, (+/-)- (UNII: D81QY6I88E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10967-608-34 100 mL in 1 CONTAINER; Type 0: Not a Combination Product 01/01/2014 2 NDC:10967-608-22 66 mL in 1 CONTAINER; Type 0: Not a Combination Product 01/01/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part350 01/01/2014 MITCHUM CLEAR GEL
aluminum sesquichlorohydrate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10967-612 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALUMINUM SESQUICHLOROHYDRATE (UNII: UCN889409V) (ALUMINUM SESQUICHLOROHYDRATE - UNII:UCN889409V) ALUMINUM SESQUICHLOROHYDRATE 0.25 g in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCERIN (UNII: PDC6A3C0OX) PEG-12 DIMETHICONE (UNII: ZEL54N6W95) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) DIPROPYLENE GLYCOL (UNII: E107L85C40) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) LINALOOL, (+/-)- (UNII: D81QY6I88E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10967-612-34 100 mL in 1 CONTAINER; Type 0: Not a Combination Product 01/01/2014 2 NDC:10967-612-22 66 mL in 1 CONTAINER; Type 0: Not a Combination Product 01/01/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part350 01/01/2014 Labeler - Revlon Consumer Products Corp (788820165) Establishment Name Address ID/FEI Business Operations REVLON, INC. 809725570 manufacture(10967-603, 10967-604, 10967-605, 10967-607, 10967-608, 10967-611, 10967-647, 10967-612, 10967-648)
