HAND-E-FOAM- otc antimicrobial drug products aerosol, foam 
DermaRite Industries, LLC

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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DRUG LISTING: HAND-E-FOAM

Active Ingredient:

Benzethonium Chloride 0.20%

Purpose:

Antiseptic Handwash

Uses:

Warnings:

Warnings

Directions:

Other Information:

Store at room temperature (59°-86°F)

Inactive Ingredients:

Benzalkonium Chloride, Cetrimonium Chloride, Diazolidinyl Urea, Fragrance, Glycerin, Hydroxethyl Cetyldimonium Phosphate, Methylchloroisothiazolinone, Methylisothiazolinone, Methylparaben, PEG-40 Dimethicone, PEG-40 Hydrogenated Castor Oil, PEG-8 Ricinoleate, Propylene Glycol, Propylparaben, Sodium Hydroxide, Tocopheryl Acetate, Water

Hand-E-Foam Package Label Principal Display Panel

HandEFoam 34oz bottle and case labels.jpgHandEFoam 1pt7 and 8oz bottle and case labels

HAND-E-FOAM 
otc antimicrobial drug products aerosol, foam
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61924-102
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.002 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROXYETHYL CETYLDIMONIUM PHOSPHATE (UNII: 9G05UO431K)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
PEG-8 RICINOLEATE (UNII: DM36F4D2OU)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61924-102-08237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/08/2002
2NDC:61924-102-1750 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/08/2002
3NDC:61924-102-341000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product08/08/2002
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/08/2002
Labeler - DermaRite Industries, LLC (883925562)
Registrant - DermaRite Industries, LLC (883925562)
Establishment
NameAddressID/FEIBusiness Operations
DermaRite Industries, LLC883925562manufacture(61924-102)

Revised: 12/2022
Document Id: efd152e8-8c38-5fad-e053-2995a90a2297
Set id: 00d2afd0-58b5-4aba-a762-d10ef1bc3f58
Version: 7
Effective Time: 20221214
 
DermaRite Industries, LLC