HAND WASH- benzalkonium chloride soap

Hand wash by

Drug Labeling and Warnings

Hand wash by is a Otc medication manufactured, distributed, or labeled by Fred's Inc, Vi-Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Benzalkonium chloride 0.13%

Purpose

Antibacterial

Use

for handwashing to decrease bacteria on the skin

Warnings

For external use only-hands only

When using this product

• avoid contact with eyes.  If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if

• irritation or redness develops
• condition persists for more than 72 hours

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• wet hands
• apply palmful to hands
• scrub thoroughly
• rinse thoroughly

Inactive ingredients

water, lauramine oxide, cocamidopropyl betaine, lauramidopropylamine oxide, sodium chloride, myristamidopropylamine oxide, glycerin, fragrance, disteareth-75 IPDI, PEG-150 distearate, citric acid, tetrasodium EDTA, benzophenone-4, sodium benzoate, red 4, yellow 5

Adverse reaction section

DISTRIBUTED BY: fred's Inc.

4300 NEW GETWELL ROAD

MEMPHIS, TN 38118

www.fredsinc.com

100% satisfactuion guaranteed

Questions or comments: 1-855-331-FRED (3733)

403.002/403AC

principal display panel

freds

Phamacy

CLEAR

AMBER

ANTIBACTERIAL

LIQUID HAND SOAP

Original Scent

Contains Moisturizers

7.5 FL OZ (221 mL)

INGREDIENTS AND APPEARANCE

HAND WASH 
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55315-403
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
MYRISTAMIDOPROPYLAMINE OXIDE (UNII: 3HSF539C9T)
glycerin (UNII: PDC6A3C0OX)
DISTEARETH-75 ISOPHORONE DIISOCYANATE (UNII: 5365FJ30SC)
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE SODIUM (UNII: MP1J8420LU)
SULISOBENZONE (UNII: 1W6L629B4K)
SODIUM BENZOATE (UNII: OJ245FE5EU)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55315-403-96	221 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/23/2015
2	NDC: 55315-403-49	443 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/23/2015
3	NDC: 55315-403-64	1893 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/23/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/23/2015

Labeler - Fred's Inc (005866116)

Registrant - Vi-Jon (005866116)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-jon		088520668	manufacture(55315-403)