PREMIUM HAND SANITIZER- benzalkonium chloride liquid 
MD Science Lab 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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PREMIUM HAND SANITIZER

Drug Facts

Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

Antimicrobial

Use

Warnings

  • When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

  • Stop use and a ask doctor if irritation or redness develops, or if 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

Inactive Ingredients

Water (aqua), Propylene Glycol, Polysorbate 20, Phenoxyethanol, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Lavandula Angustifolia (Lavender) Oil, Aloe barbadensis (Aloe Vera).

PRINCIPAL DISPLAY PANEL - 237 ml Bottle Label

M.D.
Science Lab
LLC

PREMIUM
hand
sanitizer
with Tea Tree Oil & Aloe

Kills 99.99% of Germs

Antimicrobial - Alcohol Free

moisturizes & softens skin

8 fl oz 237ml e

PRINCIPAL DISPLAY PANEL - 237 ml Bottle Label
PREMIUM HAND SANITIZER 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69898-501
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzalkonium Chloride (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) Benzalkonium Chloride1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
TEA TREE OIL (UNII: VIF565UC2G)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Polysorbate 20 (UNII: 7T1F30V5YH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69898-501-08236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/05/2020
2NDC:69898-501-12354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/05/2020
3NDC:69898-501-32946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/05/2020
4NDC:69898-501-013785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/05/2020
5NDC:69898-501-07221 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333E04/05/2020
Labeler - MD Science Lab LLC (054484289)

Revised: 4/2020
Document Id: 9e774ccd-eabf-4f7e-bbe6-aa5a21226130
Set id: 002affb4-0499-4c16-bd7f-cff06e9d4e8b
Version: 2
Effective Time: 20200429
 
MD Science Lab LLC