Label: 1438 DYNASOAP- antibacterial hand soap soap
- NDC Code(s): 67777-319-01, 67777-319-02
- Packager: Dynarex Corporation
- 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 November 30, 2022
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INGREDIENTS AND APPEARANCE
1438 DYNASOAP
antibacterial hand soap soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67777-319 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g in 100 g Inactive Ingredients Ingredient Name Strength SULISOBENZONE (UNII: 1W6L629B4K) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) LAURYL GLUCOSIDE (UNII: 76LN7P7UCU) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) GLYCERIN (UNII: PDC6A3C0OX) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) COCO DIETHANOLAMIDE (UNII: 92005F972D) SODIUM CHLORIDE (UNII: 451W47IQ8X) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) WATER (UNII: 059QF0KO0R) BENZYL ALCOHOL (UNII: LKG8494WBH) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Product Characteristics Color blue Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67777-319-01 24 in 1 CASE 08/01/2020 1 NDC:67777-319-02 0.13 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 08/01/2020 Labeler - Dynarex Corporation (008124539) Registrant - Dynarex Corporation (008124539) Establishment Name Address ID/FEI Business Operations Hobi Kozmetic Imalat Sanayi Ve Ticaret Anonim Sirketi 533139227 manufacture(67777-319)