ONEKA HAND SANITIZER LEMON- alcohol liquid 
Ecoterre Distribution Inc.

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.

----------

Oneka Hand Sanitizer Lemon

DRUG FACTS

Active ingredients:

70% organic ethyl alcohol

Purpose

Antiseptic skin cleanser

Uses

Antiseptic (skin) cleanser • Antibacterial (skin) cleanser • Kills harmful bacteria and germs • Effective in destroying (harmful) bacteria to provide antiseptic cleansing

WARNINGS

For external use only

Flammability Warning Keep away from open flame or sources of heat.

When using this product

avoid contact with eyes. If contact occurs, rinse thoroughly with water

Stop use and consult a health care professional

if irritation develops

Keep out of reach of children.

If swallowed, call a poison control center or get medical help right away

Directions

Adults and children over 2 years • For occasional and personal domestic use • Supervise children when they use this product • Rub thoroughly into hands for at least 30 seconds. Allow to dry.

Other information:

Store below 35 Cº 

Inactive ingredients

Organic Aloe Barbadensis (Aloe vera) leaf juice, Organic Salvia officinalis (Sage) extract, Organic Calendula officinalis flower extract, Citrus Limonium (Lemon) essential oil, Salvia officinalis (Sage) essential oil, Glycerin (vegetable).

Questions?

1-450-524-3737

Package Labeling:4L

BottleLabel

Package Labeling:500ml

Bottle2

Package Labeling:60ml

Bottle3

ONEKA HAND SANITIZER LEMON 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81070-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SAGE (UNII: 065C5D077J)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
LEMON (UNII: 24RS0A988O)  
SAGE OIL (UNII: U27K0H1H2O)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81070-100-034000 mL in 1 BOTTLE; Type 0: Not a Combination Product12/01/2020
2NDC:81070-100-02500 mL in 1 BOTTLE; Type 0: Not a Combination Product12/01/2020
3NDC:81070-100-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product12/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E12/01/2020
Labeler - Ecoterre Distribution Inc. (252480962)
Registrant - Pragmatic Compliance LLC (Corporation) (080611257)

Revised: 1/2022
Document Id: d4fffdad-fef1-1993-e053-2a95a90a1ffd
Set id: b63507e8-9c65-ed5b-e053-2995a90a9b33
Version: 3
Effective Time: 20220107
 
Ecoterre Distribution Inc.