ONEKA HAND SANITIZER LEMON- alcohol liquid

Oneka Hand Sanitizer Lemon by

Drug Labeling and Warnings

Oneka Hand Sanitizer Lemon by is a Otc medication manufactured, distributed, or labeled by Ecoterre Distribution Inc., Pragmatic Compliance LLC (Corporation). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Package Labeling:500ml

Package Labeling:60ml

INGREDIENTS AND APPEARANCE

ONEKA HAND SANITIZER LEMON 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81070-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81070-100-03	4000 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2020
2	NDC: 81070-100-02	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2020
3	NDC: 81070-100-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	12/01/2020

Labeler - Ecoterre Distribution Inc. (252480962)

Registrant - Pragmatic Compliance LLC (Corporation) (080611257)