EVERY DAY SHEA FOAMING SHEA BUTTER HAND SANITIZER UNSCENTED - benzalkonium chloride lotion
Agbanga Karite LLC, dba EveryDay Shea

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Every Day Shea Foaming Shea Butter Hand Sanitizer Unscented

Drug Facts

Active Ingredient

Benzalkonium Chloride 0.11%

Purpose

Antibacterial

Uses

For hand sanitizing to reduce bacteria on skin
Recommended for repeated use.

Warnings

For external use only

When using this product avoid contact with eyes. In case of eye contact, flush with water.

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away. Stop use if significant irritation or sensitization occurs.

Directions

Pump a small amount of foam into palm of hand
Rub thoroughly over all surfaces of both hands
Rub hands together briskly until dry

Inactive Ingredients

Neem Leaf Extract (aqueous), Decyl Polyglucose, Shea Butter (Butyrospermum parkii), Emulsifying Wax, Stearic Acid, Citric Acid.

Questions: call 1-800-664-8009

Handmade in the USA by Allafia

www.EveryDayShea.com

Olympia, WA 98501

Every Day Shea Foaming Shea Butter Hand Sanitizer Unscented 12oz (51441-010-12)

EVERY DAY SHEA FOAMING SHEA BUTTER HAND SANITIZER UNSCENTED
benzalkonium chloride lotion

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:51441-010
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (BENZALKONIUM)	BENZALKONIUM CHLORIDE	1.1 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
AZADIRACHTA INDICA LEAF
SHEA BUTTER
CETOSTEARYL ALCOHOL
BEHENTRIMONIUM CHLORIDE
DECYL GLUCOSIDE
STEARIC ACID
CITRIC ACID MONOHYDRATE

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51441-010-12	355 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333E	06/25/2012

Labeler - Agbanga Karite LLC, dba EveryDay Shea (614221104)

Registrant - Agbanga Karite LLC, dba EveryDay Shea (614221104)

Name	Address	ID/FEI	Business Operations
Establishment
Agbanga Karite LLC, dba EveryDay Shea		614221104	manufacture

Revised: 6/2012

Document Id: a8b50c76-267b-42c9-a854-bcabdb724a67

Set id: 883a5d10-f2cc-4475-a45f-eab6b35df6e2

Version: 2

Effective Time: 20120627

Agbanga Karite LLC, dba EveryDay Shea