San-E-Foam (Otc Antimicrobial Drug Products) Aerosol, Foam [Dermarite Industries Llc] -

SAN-E-FOAM (OTC ANTIMICROBIAL DRUG PRODUCTS) AEROSOL, FOAM [DERMARITE INDUSTRIES LLC]
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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

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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	10/12/2012

Labeler - Dermarite Industries LLC (883925562)

Registrant - Dermarite Industries, LLC (883925562)

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

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Medic