EVERY DAY SHEA MOISTURIZING SHEA BUTTER HAND SANITIZER LAVENDER - alcohol 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 Moisturizing Shea Butter Hand Sanitizer Lavender

Drug Facts

Active Ingredient

Ethyl Alcohol 62%

Purpose

Antibacterial

Uses

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

Warnings

For external use only

Flammable, keep away from fire or flame.

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

Apply one pump of moisturizing sanitizer to dry hands.Rub into skin. No rinsing required.
Supervise children in the use of this product.

Inactive Ingredients

Neem Leaf Extract (aqueous), Shea Butter (Butyrospermum parkii), Emulsifying Wax, Cetearyl Alcohol and Behentrimonium Chloride, Lavender Essential Oil.

Questions: call 1-800-664-8009

Handmade in the USA by Allafia

www.EveryDayShea.com

Olympia, WA 98501

Every Day Shea Moisturizing Shea Butter Hand Sanitizer Lavender 12oz (51441-001-12)

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EVERY DAY SHEA MOISTURIZING SHEA BUTTER HAND SANITIZER LAVENDER
alcohol lotion

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:51441-001
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (ALCOHOL)	ALCOHOL	62 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
AZADIRACHTA INDICA LEAF
SHEA BUTTER
CETOSTEARYL ALCOHOL
BEHENTRIMONIUM CHLORIDE
LAVENDER OIL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51441-001-12	355 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	06/21/2012	02/20/2014

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(51441-001)

Revised: 2/2014

Document Id: 98709c39-eccf-46e5-922d-5fd157ea940b

Set id: d67aba98-a5c2-4e39-adc0-44a41f9a4d28

Version: 2

Effective Time: 20140220

Agbanga Karite LLC, dba EveryDay Shea