Label: DERMAKLEEN- antimicrobial drug product soap
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Contains inactivated NDC Code(s)
NDC Code(s): 61924-092-01, 61924-092-08, 61924-092-16, 61924-092-27, view more61924-092-34 - Packager: Dermarite Industries LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 13, 2022
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- Active Ingredient:
- Purpose:
- Uses:
- Warnings
- Warnings
- Directions:
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Inactive Ingredients:
Cocamide MEA, Cocamidoproplyl Betaine, Citric Acid, DMDM Hydantoin, D&C Green#6, Fragrance, Glycerin, Methylchloroisothiazolinone, Methylparaben, Methylisothiazolinone, Propylene Glycol, Propylparaben, Sodium Chloride, Sodium Hydroxide, Sodium Laureth Sulfate, Sodium Lauryl Sulfate, Tetrasodium EDTA, Tocopheryl Acetate, Water.
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INGREDIENTS AND APPEARANCE
DERMAKLEEN
antimicrobial drug product soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61924-092 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL 0.002 g in 1 mL Inactive Ingredients Ingredient Name Strength COCO MONOETHANOLAMIDE (UNII: C80684146D) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) SODIUM LAURYL SULFATE (UNII: 368GB5141J) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DMDM HYDANTOIN (UNII: BYR0546TOW) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) EDETATE SODIUM (UNII: MP1J8420LU) SODIUM HYDROXIDE (UNII: 55X04QC32I) GLYCERIN (UNII: PDC6A3C0OX) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) D&C GREEN NO. 6 (UNII: 4QP5U84YF7) WATER (UNII: 059QF0KO0R) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM CHLORIDE (UNII: 451W47IQ8X) Product Characteristics Color green Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61924-092-08 222 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 05/15/2012 2 NDC:61924-092-01 3800 mL in 1 JUG; Type 0: Not a Combination Product 06/01/2012 3 NDC:61924-092-34 1000 mL in 1 BAG; Type 0: Not a Combination Product 06/01/2012 4 NDC:61924-092-27 800 mL in 1 BAG; Type 0: Not a Combination Product 06/01/2012 5 NDC:61924-092-16 473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 09/09/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/15/2012 Labeler - Dermarite Industries LLC (883925562) Registrant - DermaRite Industries, LLC (883925562) Establishment Name Address ID/FEI Business Operations Dermarite Industries LLC 883925562 manufacture(61924-092)