BENZALKONIUM CHLORIDE- benzalkonium chloride 0.13% soap

Benzalkonium chloride by

Drug Labeling and Warnings

Benzalkonium chloride by is a Otc medication manufactured, distributed, or labeled by HEB, Vi-Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Benzalkonium chloride 0.13%

Purpose

Antibacterial

Use

for handwashing to decrease bacteria on the skin

Warnings

For external use only: hand 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, cocamidopropyl betaine, lauramine oxide, PEG-150 distearate, sodium chloride, cetrimonium chloride, decyl glucoside, glycerin, fragrance, disteareth-75 IPID, citric acid, tetrasodium EDTA, DMDM hydantoin, benzophenone-4, yellow 5, red 40, red 33

Questions?

Call 1-888-593-0593

SPL UNCLASSIFIED SECTION

Distributed by HEB San Antonio, TX 78204

Made in the USA of US and Imported Parts

We hope you are satisfied with this product.  If not, we will cheerfully refund your money.  Lot number: on package.  1-888-593-0593

principal display panel

Hill Country Essentials

Antibacterial Hand Soap

Moisturizing

7.5 FL OZ (221 mL)

279.002/279AB-AC

INGREDIENTS AND APPEARANCE

BENZALKONIUM CHLORIDE 
benzalkonium chloride 0.13% soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37808-278
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 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
GLYCERIN (UNII: PDC6A3C0OX)
DISTEARETH-75 ISOPHORONE DIISOCYANATE (UNII: 5365FJ30SC)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE SODIUM (UNII: MP1J8420LU)
DMDM HYDANTOIN (UNII: BYR0546TOW)
SULISOBENZONE (UNII: 1W6L629B4K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C RED NO. 40 (UNII: WZB9127XOA)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37808-278-96	221 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/03/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/03/2016

Labeler - HEB (007924756)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		088520668	manufacture(37808-278)