Primal Elements Antibacterial: Package Insert and Label Information

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.

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

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PRIMAL ELEMENTS ANTIBACTERIAL
benzalkonium chloride lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68062-2293
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 0.295 mg in 227 mg
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68062-2293-1 227 mg in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 10/01/2020
Labeler — Spa de Soleil (874682867)
Establishment
Name Address ID/FEI Operations
Spa de Soleil 874682867 manufacture (68062-2293)

Revised: 10/2020 Spa de Soleil

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