Your browser does not support JavaScript! EO HAND SANITIZER LAVENDER (ALCOHOL) GEL [SMALL WORLD TRADING COMPANY]
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EO HAND SANITIZER LAVENDER (alcohol) gel
[Small World Trading Company]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:54748-201
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (ALCOHOL) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
LAVENDER OIL 
LAVANDIN OIL 
JOJOBA OIL 
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) 
DIMETHICONE 
AMINOMETHYLPROPANOL 
GLYCERIN 
Packaging
#Item CodePackage Description
1NDC:54748-201-0260 mL in 1 BOTTLE
2NDC:54748-201-03240 mL in 1 BOTTLE
3NDC:54748-201-04960 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/15/2013
Labeler - Small World Trading Company (786611210)
Establishment
NameAddressID/FEIBusiness Operations
Small World Trading Company786611210manufacture(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

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