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

SAN-E-FOAM by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredient:

Ethyl Alcohol 67%

Purpose:

Antiseptic

Uses:

• For handwashing to decrease bacteria on the skin.
• Recommended for repeated use.

Warnings:

For external use only.

Flammable. Keep away from heat or flame.

Avoid contact with eyes. In case of contact, flush thoroughly with water.

Stop use and ask a doctor if skin irritation develops.

KEEP OUT OF REACH OF CHILDREN

In case of accidental ingestion contact a physician or Poison Control Center right away.

Directions

• Wet hands thoroughly with product.
• Briskly rub hands until dry.
• Supervise children in the use of this product.

Other Information

• Do not store above 105°F. May discolor some fabrics or surfaces.
• May report serious adverse events to DermaRite Industries, PO Box 7209, North Bergen, NJ 07047

INACTIVE INGREDIENT

San-E-Foam Package Label Principal Display Panel

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61924-107
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.67 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61924-107-17	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/12/2012
2	NDC: 61924-107-34	1000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	10/12/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/12/2012

Labeler - Dermarite Industries LLC (883925562)

Registrant - Dermarite Industries, LLC (883925562)

Establishment
Name	Address	ID/FEI	Business Operations
Dermarite Industries LLC		883925562	manufacture(61924-107)