RAW SPIRIT - MOISTURIZING ANTIMICROBIAL HAND- benzalkonium chloride lotion

Raw Spirit - Moisturizing Antimicrobial Hand by

Drug Labeling and Warnings

Raw Spirit - Moisturizing Antimicrobial Hand by is a Otc medication manufactured, distributed, or labeled by Cosmetic Solutions LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS:

ACTIVE INGREDIENTS

Benzalkonium chloride 0.13%

Purpose

Antiseptic

USES

To decrease bacteria on the skin.

WARNINGS

• For external use only: Hands only.

• When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. Avoid contact with broken skin.

• Stop use and ask a doctor if irritation or redness develops - condition persists for more than 72 hours.

• Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

Wet hands thoroughly with product and allow to dry without wiping - for children under 6, use only under adult supervision - not recommended for infants.

INACTIVE INGREDIENTS

Water (Aqua), Caprylic/Capric Triglyceride, Cetyl Alcohol, Behentrimonium Methosulfate, Carthamus Tinctorius Seed Oil, Dimethicone, Propanediol, Butylene Glycol, Calendula Officinalis Flower Extract, Citric Acid, Disodium Phosphate, Equisetum Arvense Extract, Ethylhexylglycerin, Fragrance, Geranium Maculatum Extract, Glycerin, Honey, Lactococcus Ferment Extract, Moringa Oleifera Seed Extract, Panax Ginseng Root Extract, Phenoxyethanol, Salvia Officinalis Leaf Extract, Sambucus Nigra Flower Extract, Sodium Hydroxide.

PRINCIPAL DISPLAY PANEL - 60 g Bottle Label

RAW
SPIRIT

moisturizing
antimicrobial
hand lotion

Net wt. 2.1 oz | 60g

INGREDIENTS AND APPEARANCE

RAW SPIRIT - MOISTURIZING ANTIMICROBIAL HAND 
benzalkonium chloride lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66163-2101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Medium-Chain Triglycerides (UNII: C9H2L21V7U)
Cetyl Alcohol (UNII: 936JST6JCN)
BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)
Safflower Oil (UNII: 65UEH262IS)
Dimethicone (UNII: 92RU3N3Y1O)
Propanediol (UNII: 5965N8W85T)
Butylene Glycol (UNII: 3XUS85K0RA)
Calendula Officinalis Flower (UNII: P0M7O4Y7YD)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Sodium Phosphate, Dibasic, Anhydrous (UNII: 22ADO53M6F)
EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E)
Ethylhexylglycerin (UNII: 147D247K3P)
GERANIUM MACULATUM ROOT (UNII: 93IXI5B6OJ)
Glycerin (UNII: PDC6A3C0OX)
Honey (UNII: Y9H1V576FH)
Asian Ginseng (UNII: CUQ3A77YXI)
Phenoxyethanol (UNII: HIE492ZZ3T)
Sambucus Nigra Flower (UNII: 07V4DX094T)
Sodium Hydroxide (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66163-2101-1	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part333E	05/01/2020

Labeler - Cosmetic Solutions LLC (807907928)