EO HAND SANITIZER LAVENDER- alcohol gel 
Small World Trading Company

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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Drug Facts

Active Ingredient:

Ethanol 62%

Purpose:

Antiseptic

Keep out of reach of children

Uses: For hand  washing  to  decrease bacteria on skin. Recommended for repeated use

Warnings:

For external use only
Flammable
Keep away from fire/flame
Do not use this product in or near eyes. If contact occurs, rinse thoroughly with water
keep out of reach of children
Children under 6 years of age should be supervised when using this product

Directions:

Put a small drop onto palm, Rub hands together.

Inactive Ingredients:

Purified Water, Vegetable Glycerin, EO Essential Oil Blend [ Organic Lavandula Hybrida Angustifolia (Lavender) Oil, Lavandula Hybrida Oil, Organic Simmondsia Chinensis (Jojoba) Seed Oil, Carbomer, Dimethicone, Aminomethyl Propanol.


Other Information:

Do not store above 104°F / 40°C, May discolor some fabrics.

Drug Label

EO HAND SANITIZER  LAVENDER
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:54748-201
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 62 mL  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
LAVANDIN OIL (UNII: 9RES347CKG)  
JOJOBA OIL (UNII: 724GKU717M)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:54748-201-02 60 mL in 1 BOTTLE
2 NDC:54748-201-03 240 mL in 1 BOTTLE
3 NDC:54748-201-04 960 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 01/15/2013
Labeler - Small World Trading Company (786611210)
Establishment
Name Address ID/FEI Business Operations
Small World Trading Company 786611210 manufacture(54748-201)

Revised: 12/2012
Document Id: 463c312a-3d20-47e5-94cf-dfe40b027762
Set id: 36b26803-ed48-498f-bc0e-15473495a35a
Version: 1
Effective Time: 20121222
 
Small World Trading Company