RAW SPIRIT - MOISTURIZING HAND SANITIZER FOAM- benzalkonium chloride liquid 
Cosmetic Solutions LLC

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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Raw Spirit - Moisturizing Hand Sanitizer Foam

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), Propanediol, Glycereth-7 Triacetate, Glycerin, Babassu Oil Glycereth-8 Esters, Decyl Glucoside, Calendula Officinalis Flower Extract, Equisetum Arvense Extract, Geranium Maculatum Extract, Honey, Citric Acid, Panax Ginseng Root Extract, Salvia Officinalis Leaf Extract, Sambucus Nigra Flower Extract, Ethylhexylglycerin, Phenoxyethanol, Sodium Hydroxide.

PRINCIPAL DISPLAY PANEL - 120 ml Bottle Label

RAW
SPIRIT

moisturizing
antimicrobial
foam

4.1 fl. oz | 120ml

PRINCIPAL DISPLAY PANEL - 120 ml Bottle Label
RAW SPIRIT - MOISTURIZING HAND SANITIZER FOAM 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66163-1901
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Propanediol (UNII: 5965N8W85T)  
Glycereth-7 Triacetate (UNII: S9W6Z48HUP)  
Glycerin (UNII: PDC6A3C0OX)  
Babassu Oil Glycereth-8 Esters (UNII: 12XQ76K0YL)  
Decyl Glucoside (UNII: Z17H97EA6Y)  
Calendula Officinalis Flower (UNII: P0M7O4Y7YD)  
Equisetum Arvense Branch (UNII: 1L0VKZ185E)  
Geranium Maculatum Root (UNII: 93IXI5B6OJ)  
Honey (UNII: Y9H1V576FH)  
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
Asian Ginseng (UNII: CUQ3A77YXI)  
Sambucus Nigra Flower (UNII: 07V4DX094T)  
Ethylhexylglycerin (UNII: 147D247K3P)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66163-1901-1120 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333E06/01/2020
Labeler - Cosmetic Solutions LLC (807907928)

Revised: 7/2020
Document Id: 270eff7d-4821-4b2e-9ef5-0e8390ab3d01
Set id: aacc451e-ff51-4caf-88dc-3a26e4975f0d
Version: 1
Effective Time: 20200716
 
Cosmetic Solutions LLC