Primal Elements Hand Sanitizing Lotion

Primal Elements Antibacterial by

Drug Labeling and Warnings

Primal Elements Antibacterial by is a Otc medication manufactured, distributed, or labeled by Spa de Soleil. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRIMAL ELEMENTS ANTIBACTERIAL- benzalkonium chloride lotion 
Spa de Soleil

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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Primal Elements Hand Sanitizing Lotion

Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

Antiseptic

Warnings

Warnings

For external use only. If product gets in eyes, rinse promptly and thoroughly with water. Discontinue use if irritation and redness occur.

Stop use and ask a doctor if irritation or redness lasts for more than 72 hours. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Keep out of reach of children.

Directions

Place enough product in the palm of your hands to thoroughly cover your hands. Rub hands together until dry.

Place enough product in the palm of your hands to thoroughly cover you hands. Rub hands together briskly until product is completely absorbed and hands are dry.

Inactive Ingredients:

Inactive Ingredients

Inactive Ingredients:

Aqua, Isononyl Isononanoate, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Palmitoyl Tripeptide-5, Glycerin, *CO Glycerin, *CO Humulus Lupulus (Hops) Extract, *CO Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract, *CO Calendula Officinalis Flower Extract, *CO Chamomilla Recutita (Matricaria) Flower Extract, *CO Citrus Limon (Lemon) Peel Extract, *CO Cucumis Sativus (Cucumber) Seed Extract, *CO Camellia Sinensis Leaf Extract, *CO Pyrus Malus (Apple) Fruit Extract, *CO Spirulina Platensis Extract, Ascorbic Acid (Vitamin C), Retinyl Palmitate (Vitamin A), Tocopheryl Acetate (Vitamin E), Benzyl Alcohol, Dehydroacetic Acid, Fragrance. *CO Certified Organic

PRIMAL ELEMENTS ANTIBACTERIAL 
benzalkonium chloride lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68062-2293
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.295 mg  in 227 mg

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68062-2293-1	227 mg in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/01/2020	01/08/2023

Labeler - Spa de Soleil (874682867)

Establishment
Name	Address	ID/FEI	Business Operations
Spa de Soleil		874682867	manufacture(68062-2293)

Revised: 1/2023

Document Id: f1c94183-4c54-ffa7-e053-2a95a90ac919

34390-5

Set id: b0a23409-910f-7263-e053-2995a90ae2c8

Version: 2

Effective Time: 20230108