HAND-E-FOAM- otc antimicrobial drug products aerosol, foam

HAND-E-FOAM by

Drug Labeling and Warnings

HAND-E-FOAM by is a Otc medication manufactured, distributed, or labeled by DermaRite Industries, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient:

Benzethonium Chloride 0.20%

Purpose:

Antiseptic Handwash

Uses:

• Hand sanitizer: Helps reduce bacteria on skin that could cause disease. Recommended for repeated use.
• First aid to help protect against skin infection in minor cuts, scrapes, burns.

Warnings:

• For external use only.
• Avoid contact with eyes. In case of contact, flush thoroughly with water.
• When using this product do not apply to large area of raw or blistered skin in large quantities; do not use in or near the eyes. 

• Ask a doctor before use if you have , deep of puncture wounds, animal bites, serious burns

Warnings

• Keep out of reach of children. In case of accidental ingestion contact a physician or Poison Control Center right away

Directions:

• Hand sanitizer: Wet hands thoroughly with product and allow to dry without wiping. Children should be supervised when using this product.
• First Aid: Clean the affected area whenever possible. Apply to affected area not more than 3 to 4 times daily. May be covered with a sterile bandage:if bandaged, let dry first.

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

INGREDIENTS AND APPEARANCE

HAND-E-FOAM 
otc antimicrobial drug products aerosol, foam

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61924-102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP)	BENZETHONIUM CHLORIDE	0.002 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61924-102-08	237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/08/2002
2	NDC: 61924-102-17	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/08/2002
3	NDC: 61924-102-34	1000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	08/08/2002

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/08/2002

Labeler - DermaRite Industries, LLC (883925562)

Registrant - DermaRite Industries, LLC (883925562)

Establishment
Name	Address	ID/FEI	Business Operations
DermaRite Industries, LLC		883925562	manufacture(61924-102)